A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy (OAK)

• ClinicalTrials.gov Identifier: NCT02008227
• Recruitment Status: Completed
• First Posted: December 11, 2013
• Results First Posted: July 2, 2017
• Last Update Posted: December 20, 2019
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: Atezolizumab; Drug: Docetaxel
• Enrollment: 1225

Participant Flow

Recruitment Details
Pre-assignment Details	Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Period Title: Overall Study
Started	612	613
Treated	579	608
Completed	0	0
Not Completed	612	613
Reason Not Completed
Lost to Follow-up	7	9
Death	494	485
Withdrawal by Subject	67	36
Study Terminated By Sponsor	44	83

Baseline Characteristics

Arm/Group Title		Docetaxel	Atezolizumab	Total
Arm/Group Description		Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Total of all reporting groups
Overall Number of Baseline Participants		612	613	1225
Baseline Analysis Population Description		SP-Intent to Treat (ITT) analysis set included all randomized ITT participants regardless of whether they received any study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	612 participants	613 participants	1225 participants
		62.9 (9.2)	62.7 (9.8)	62.8 (9.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	612 participants	613 participants	1225 participants
	Female	233 38.1%	234 38.2%	467 38.1%
	Male	379 61.9%	379 61.8%	758 61.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	612 participants	613 participants	1225 participants
	Hispanic or Latino	42 6.9%	48 7.8%	90 7.3%
	Not Hispanic or Latino	541 88.4%	540 88.1%	1081 88.2%
	Unknown or Not Reported	29 4.7%	25 4.1%	54 4.4%
Race/Ethnicity, Customized [1]; Measure Type: Number; Unit of measure: Participants
American Indian or Alaska Native	Number Analyzed	2 participants	1 participants	3 participants
		2	1	3
Asian	Number Analyzed	125 participants	124 participants	249 participants
		125	124	249
Black or African American	Number Analyzed	16 participants	11 participants	27 participants
		16	11	27
Native Hawaiian or other Pacific Islander	Number Analyzed	2 participants	3 participants	5 participants
		2	3	5
White	Number Analyzed	432 participants	438 participants	870 participants
		432	438	870
Other	Number Analyzed	12 participants	11 participants	23 participants
		12	11	23
Multiple	Number Analyzed	1 participants	2 participants	3 participants
		1	2	3
Unknown	Number Analyzed	22 participants	23 participants	45 participants
		22	23	45
		[1] Measure Analysis Population Description: SP-ITT Population

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Died: PP-ITT
Description	[Not Specified]
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Measure Type: Number; Unit of Measure: Percentage of Participants
	70.1	63.8

2. Primary Outcome

Title	Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Description	Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	222	241
Measure Type: Number; Unit of Measure: Percentage of Participants
	67.1	62.7

3. Primary Outcome

Title	Overall Survival (OS): PP-ITT
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Median (95% Confidence Interval); Unit of Measure: Months
	9.6; (8.6 to 11.2)	13.8; (11.8 to 15.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.87
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.86
	Estimation Comments	[Not Specified]

4. Primary Outcome

Title	OS: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	222	241
Median (95% Confidence Interval); Unit of Measure: Months
	10.3; (8.8 to 12.0)	15.7; (12.6 to 18.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0102
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.93
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0052
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.91
	Estimation Comments	[Not Specified]

5. Primary Outcome

Title	OS: SP-ITT
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	612	613
Median (95% Confidence Interval); Unit of Measure: Months
	9.8; (8.8 to 11.3)	13.3; (11.3 to 14.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.92
	Estimation Comments	[Not Specified]

6. Primary Outcome

Title	OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death from any cause (approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 Or IC1/2/3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	337	347
Median (95% Confidence Interval); Unit of Measure: Months
	10.8; (9.3 to 12.0)	14.3; (12.4 to 16.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0045
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.92
	Estimation Comments	[Not Specified]

7. Primary Outcome

Title	OS: TC2/3 or IC2/3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC2/3 or IC2/3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	182	168
Median (95% Confidence Interval); Unit of Measure: Months
	11.4; (9.3 to 12.9)	16.6; (13.6 to 20.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.84
	Estimation Comments	[Not Specified]

8. Primary Outcome

Title	OS: TC3 or IC3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC3 or IC3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	85	89
Median (95% Confidence Interval); Unit of Measure: Months
	9.7; (7.9 to 11.6)	20.5; (16.8 to 30.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.68
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
Description	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
Time Frame	Baseline up to PD or Death (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Measure Type: Number; Unit of Measure: Percentage of Participants
	88.2	89.4

10. Secondary Outcome

Title	Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or Death (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	222	241
Measure Type: Number; Unit of Measure: Percentage of Participants
	86.9	89.6

11. Secondary Outcome

Title	Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Median (95% Confidence Interval); Unit of Measure: Months
	4.0; (3.3 to 4.2)	2.8; (2.6 to 3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4928
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.10
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3596
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.08
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	222	241
Median (95% Confidence Interval); Unit of Measure: Months
	4.1; (2.9 to 4.3)	2.8; (2.6 to 4.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3806
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.12
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3249
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.10
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Description	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	13.4; (10.32 to 17.02)	13.6; (10.53 to 17.28)

14. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	222	241
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	16.2; (11.62 to 21.74)	17.8; (13.22 to 23.27)

15. Secondary Outcome

Title	Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	57	58
Median (95% Confidence Interval); Unit of Measure: Months
	6.2; (4.9 to 7.6)	16.3 [1]; (10.0 to NA)

[1]

Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.55
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	36	43
Median (95% Confidence Interval); Unit of Measure: Months
	6.2; (4.9 to 9.2)	16.0 [1]; (9.7 to NA)

[1]

Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.62
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.65
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Description	[Not Specified]
Time Frame	Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])

Outcome Measure Data

Analysis Population Description

ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.

Arm/Group Title	Atezolizumab
Arm/Group Description:	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	565
Measure Type: Number; Unit of Measure: Percentage of Participants
	30.4

18. Secondary Outcome

Title	Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description	[Not Specified]
Time Frame	Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.

Arm/Group Title	Atezolizumab
Arm/Group Description:	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	606
Mean (Standard Deviation); Unit of Measure: Microgram per milliliter (mcg/mL)
	400 (127)

19. Secondary Outcome

Title	Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description	[Not Specified]
Time Frame	Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)

Outcome Measure Data

Analysis Population Description

PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Atezolizumab
Arm/Group Description:	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	606
Mean (Standard Deviation); Unit of Measure: mcg/mL
C1D1 (n= 593)	2.59 (30.9)
C2D1 (n= 534)	83.2 (31.0)
C3D1 (n= 445)	130 (55.8)
C4D1 (n= 405)	158 (66.4)
C8D1 (n= 222)	205 (99.4)
C16D1 (n= 132)	226 (105)
C24D1 (n= 63)	250 (99.8)
C32D1 (n= 11)	277 (117)
EOT (n= 347)	144 (101)
120 days after EOT (n= 124)	10.4 (20.0)

20. Secondary Outcome

Title	Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Description	TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Median (95% Confidence Interval); Unit of Measure: Months
Pain in Chest	8.3; (4.6 to 12.5)	18.0 [1]; (11.0 to NA)
Cough	5.6; (4.0 to 12.8)	5.5; (4.2 to 7.9)
Dyspnea	2.1; (1.6 to 2.3)	1.8; (1.5 to 2.3)
Arm/Shoulder Pain	6.2; (4.9 to 14.7)	8.3; (5.8 to 12.8)

[1]

Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0111
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.55 to 0.93
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Cough: Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6305
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.33
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Dyspnea: Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7406
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.16
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Arm/Shoulder Pain
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5221
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.17
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Description	EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Appetite Loss: Baseline (n= 390, 413)	26.58 (31.57)	22.92 (29.41)
Appetite Loss: Cycle (C) 2 Day (D) 1(n= 342, 368)	27.49 (30.39)	26.99 (31.16)
Appetite Loss: C3D1(n= 256, 304)	21.35 (28.84)	21.16 (28.94)
Appetite Loss: C4D1(n= 224, 279)	18.75 (25.36)	18.40 (26.60)
Appetite Loss: C5D1(n= 166, 238)	18.88 (23.89)	16.67 (27.52)
Appetite Loss: C6D1(n= 151, 224)	18.98 (25.68)	14.88 (25.39)
Appetite Loss: C7D1(n= 88, 190)	15.91 (24.75)	12.46 (23.06)
Appetite Loss: C8D1(n= 72, 170)	13.89 (22.20)	12.94 (23.27)
Appetite Loss: C9D1(n= 50, 153)	8.00 (18.52)	11.33 (22.35)
Appetite Loss: C10D1(n= 47, 146)	7.80 (15.87)	12.33 (21.45)
Appetite Loss: C11D1(n= 37, 134)	11.71 (23.85)	11.44 (22.43)
Appetite Loss: C12D1(n= 30, 132)	11.11 (20.22)	8.84 (18.81)
Appetite Loss: C13D1(n= 19, 123)	10.53 (15.92)	8.40 (15.74)
Appetite Loss: C14D1(n= 18, 120)	7.41 (14.26)	10.00 (17.61)
Appetite Loss: C15D1(n= 16, 113)	6.25 (13.44)	12.39 (22.80)
Appetite Loss: C16D1(n= 13, 109)	7.69 (14.62)	10.09 (19.51)
Appetite Loss: C17D1(n= 11, 98)	6.06 (13.48)	7.82 (18.41)
Appetite Loss: C18D1(n= 10, 91)	6.67 (14.05)	8.06 (18.15)
Appetite Loss: C19D1(n= 9, 84)	7.41 (14.70)	9.13 (18.18)
Appetite Loss: C20D1(n= 9, 80)	11.11 (23.57)	9.58 (21.34)
Appetite Loss: C21D1(n= 9, 75)	3.70 (11.11)	12.44 (26.15)
Appetite Loss: C22D1(n= 8, 69)	8.33 (15.43)	6.76 (16.74)
Appetite Loss: C23D1(n= 8, 66)	8.33 (15.43)	7.58 (17.34)
Appetite Loss: C24D1(n= 5, 64)	13.33 (18.26)	8.33 (15.71)
Appetite Loss: C25D1(n= 3, 60)	0.00 (0.00)	6.11 (13.01)
Appetite Loss: C26D1(n= 3, 55)	22.22 (19.24)	5.45 (12.45)
Appetite Loss: C27D1(n= 3, 52)	0.00 (0.00)	9.62 (19.06)
Appetite Loss: C28D1(n= 1, 49)	0.00 [1] (NA)	7.48 (15.61)
Appetite Loss: C29D1(n= 2, 40)	33.33 (47.14)	9.17 (16.86)
Appetite Loss: C30D1(n= 1, 31)	0.00 [2] (NA)	1.08 (5.99)
Appetite Loss: C31D1(n= 0, 24)	NA [3] (NA)	6.94 (13.83)
Appetite Loss: C32D1(n= 0, 22)	NA [3] (NA)	7.58 (22.84)
Appetite Loss: C33D1(n= 0,16)	NA [3] (NA)	8.33 (25.82)
Appetite Loss: C34D1(n= 0, 14)	NA [3] (NA)	4.76 (17.82)
Appetite Loss: C35D1(n= 0, 12)	NA [3] (NA)	8.33 (20.72)
Appetite Loss: C36D1(n= 0, 8)	NA [3] (NA)	4.17 (11.78)
Appetite Loss: C37D1(n= 0, 5)	NA [3] (NA)	6.67 (14.91)
Appetite Loss: C38D1(n= 0, 2)	NA [3] (NA)	0.00 (0.00)
Appetite Loss: End of treatment (EOT)(n= 265, 246)	29.81 (31.85)	31.98 (33.51)
Appetite Loss: Pro Week 6 Pd(n= 0,1)	NA [3] (NA)	33.33 [2] (NA)
Appetite Loss: Survival Follow-up (FU) 1 (n= 2, 1)	50.00 (70.71)	66.67 [2] (NA)
Constipation: Baseline (n= 388, 410)	19.93 (27.39)	16.50 (26.81)
Constipation: C2D1(n= 339, 363)	19.47 (26.42)	18.09 (26.92)
Constipation: C3D1(n= 255, 304)	19.74 (26.91)	15.13 (23.71)
Constipation: C4D1(n= 224, 277)	17.86 (23.38)	14.56 (23.58)
Constipation: C5D1(n= 166, 236)	13.05 (21.33)	12.15 (21.16)
Constipation: C6D1(n= 151, 225)	14.35 (23.89)	12.89 (22.42)
Constipation: C7D1(n= 87, 188)	13.41 (20.62)	11.52 (21.04)
Constipation: C8D1(n= 72, 171)	8.33 (15.57)	12.28 (21.36)
Constipation: C9D1(n= 50, 153)	9.33 (19.10)	10.68 (17.79)
Constipation: C10D1(n= 47, 146)	9.22 (17.99)	9.82 (17.58)
Constipation: C11D1(n= 37, 134)	5.41 (12.46)	9.95 (17.83)
Constipation: C12D1(n= 30, 132)	11.11 (20.22)	10.86 (18.65)
Constipation: C13D1(n= 19, 124)	5.26 (12.49)	8.60 (15.83)
Constipation: C14D1(n= 17, 121)	15.69 (23.91)	9.09 (16.67)
Constipation: C15D1(n= 15, 113)	2.22 (8.61)	10.03 (17.75)
Constipation: C16D1(n= 13, 109)	20.51 (32.03)	9.79 (18.87)
Constipation: C17D1(n= 11, 98)	12.12 (22.47)	9.86 (19.27)
Constipation: C18D1(n= 10, 92)	6.67 (14.05)	9.06 (17.89)
Constipation: C19D1(n= 9, 83)	7.41 (14.70)	9.64 (18.43)
Constipation: C20D1(n=9, 80)	14.81 (33.79)	12.50 (23.35)
Constipation: C21D1(n= 9, 75)	7.41 (14.70)	14.22 (25.22)
Constipation: C22D1(n= 8, 69)	12.50 (24.80)	11.59 (21.26)
Constipation: C23D1(n= 8, 66)	4.17 (11.78)	10.10 (20.23)
Constipation: C24D1(n=5, 65)	20.00 (29.81)	9.74 (17.40)
Constipation: C25D1(n= 3, 60)	0.00 (0.00)	11.11 (19.08)
Constipation: C26D1(n= 2, 55)	0.00 (0.00)	12.12 (20.65)
Constipation: C27D1(n= 3, 52)	0.00 (0.00)	13.46 (20.09)
Constipation: C28D1(n= 1, 48)	0.00 [2] (NA)	11.81 (22.27)
Constipation: C29D1(n= 2, 40)	50.00 (70.71)	15.83 (23.86)
Constipation: C30D1(n= 1, 31)	0.00 [2] (NA)	8.60 (19.18)
Constipation: C31D1(n= 0, 24)	NA [3] (NA)	9.72 (20.80)
Constipation: C32D1(n= 0, 22)	NA [3] (NA)	6.06 (13.16)
Constipation: C33D1(n= 0, 16)	NA [3] (NA)	4.17 (11.39)
Constipation: C34D1(n= 0, 14)	NA [3] (NA)	7.14 (14.19)
Constipation: C35D1(n= 0, 12)	NA [3] (NA)	5.56 (12.97)
Constipation: C36D1(n= 0, 8)	NA [3] (NA)	4.17 (11.78)
Constipation: C37D1(n= 0, 5)	NA [3] (NA)	0.00 (0.00)
Constipation: C38D1(n= 0, 2)	NA [3] (NA)	0.00 (0.00)
Constipation: EOT (n= 265, 246)	19.12 (27.28)	19.78 (28.36)
Constipation: Pro Week 6 Pd(n= 0,1)	NA [3] (NA)	66.67 [2] (NA)
Constipation: Survival FU-1 (n= 2,1)	33.33 (47.14)	66.67 [2] (NA)
Diarrhea: Baseline (n= 388, 411)	5.84 (13.77)	7.22 (17.86)
Diarrhea: C2D1(n= 339, 361)	11.21 (20.65)	7.29 (17.72)
Diarrhea: C3D1(n= 255, 304)	10.07 (18.68)	6.14 (15.75)
Diarrhea: C4D1(n= 223, 280)	8.22 (16.35)	6.67 (17.71)
Diarrhea: C5D1(n= 166, 238)	8.43 (17.48)	6.58 (16.16)
Diarrhea: C6D1(n= 151, 222)	7.51 (14.99)	6.31 (14.88)
Diarrhea: C7D1(n= 87, 189)	10.34 (17.10)	7.94 (17.24)
Diarrhea: C8D1(n= 72, 171)	7.41 (15.03)	8.77 (17.56)
Diarrhea: C9D1(n= 50, 153)	11.33 (17.31)	7.63 (16.44)
Diarrhea: C10D1(n= 47, 146)	7.80 (14.27)	5.48 (15.67)
Diarrhea: C11D1(n= 36, 134)	8.33 (14.64)	4.98 (14.46)
Diarrhea: C12D1(n= 30, 132)	10.00 (17.83)	6.31 (16.54)
Diarrhea: C13D1(n= 18, 124)	11.11 (16.17)	5.65 (14.55)
Diarrhea: C14D1(n= 17, 121)	3.92 (11.07)	9.92 (19.07)
Diarrhea: C15D1(n= 15, 113)	8.89 (15.26)	7.96 (17.97)
Diarrhea: C16D1(n= 12, 108)	13.89 (17.16)	6.48 (14.02)
Diarrhea: C17D1(n= 11, 98)	9.09 (15.57)	7.82 (16.44)
Diarrhea: C18D1(n= 10, 92)	13.33 (17.21)	8.70 (17.73)
Diarrhea: C19D1(n= 9, 84)	14.81 (17.57)	7.94 (18.38)
Diarrhea: C20D1(n= 9, 80)	7.41 (14.70)	6.67 (14.43)
Diarrhea: C21D1(n= 9, 75)	18.52 (17.57)	11.11 (18.45)
Diarrhea: C22D1(n= 8, 68)	16.67 (25.20)	7.84 (16.41)
Diarrhea: C23D1(n= 8, 66)	8.33 (15.43)	6.06 (16.44)
Diarrhea: C24D1(n= 5, 64)	6.67 (14.91)	6.25 (16.67)
Diarrhea: C25D1(n= 3, 60)	0.00 (0.00)	6.11 (14.38)
Diarrhea: C26D1(n= 3, 55)	11.11 (19.24)	10.30 (21.15)
Diarrhea: C27D1(n= 3, 52)	11.11 (19.24)	5.77 (15.79)
Diarrhea: C28D1(n= 1, 48)	0.00 [2] (NA)	4.86 (13.73)
Diarrhea: C29D1(n= 2, 40)	50.00 (70.71)	9.17 (18.47)
Diarrhea: C30D1(n= 1, 31)	0.00 [2] (NA)	7.53 (16.58)
Diarrhea: C31D1(n= 0, 24)	NA [3] (NA)	6.94 (16.97)
Diarrhea: C32D1(n= 0, 22)	NA [3] (NA)	12.12 (16.41)
Diarrhea: C33D1(n= 0, 16)	NA [3] (NA)	8.33 (14.91)
Diarrhea: C34D1(n= 0, 14)	NA [3] (NA)	4.76 (12.10)
Diarrhea: C35D1(n= 0, 12)	NA [3] (NA)	5.56 (12.97)
Diarrhea: C36D1(n= 0, 8)	NA [3] (NA)	4.17 (11.78)
Diarrhea: C37D1(n= 0, 5)	NA [3] (NA)	6.67 (14.91)
Diarrhea: C38D1(n= 0, 2)	NA [3] (NA)	0.00 (0.00)
Diarrhea: EOT(n= 265, 246)	10.57 (19.18)	9.35 (20.39)
Diarrhea: Pro Week 6 Pd(n= 0, 1)	NA [3] (NA)	0.00 [2] (NA)
Diarrhea: Survival FU-1 (n= 2, 1)	33.33 (47.14)	33.33 [2] (NA)
Financial Difficulties: Baseline (n=387, 411)	20.76 (27.61)	18.09 (28.32)
Financial Difficulties: C2D1 (n=336, 362)	18.45 (26.20)	15.93 (26.28)
Financial Difficulties: C3D1 (n=253, 305)	16.86 (24.24)	15.63 (25.79)
Financial Difficulties: C4D1 (n=219, 280)	16.74 (23.97)	15.12 (24.72)
Financial Difficulties: C5D1 (n=165, 238)	16.57 (24.03)	15.13 (25.71)
Financial Difficulties: C6D1 (n=149, 224)	15.66 (24.06)	16.67 (26.41)
Financial Difficulties: C7D1 (n=86, 189)	16.28 (24.92)	17.46 (27.41)
Financial Difficulties: C8D1 (n=71, 170)	13.15 (21.44)	18.82 (27.59)
Financial Difficulties: C9D1 (n=49, 152)	16.33 (28.16)	17.54 (27.38)
Financial Difficulties: C10D1 (n=46, 146)	14.49 (23.99)	17.81 (29.08)
Financial Difficulties: C11D1 (n=36, 134)	9.26 (21.98)	19.65 (30.10)
Financial Difficulties: C12D1 (n=30, 132)	12.22 (23.95)	18.43 (28.92)
Financial Difficulties: C13D1 (n=18, 122)	12.96 (25.92)	18.31 (29.10)
Financial Difficulties: C14D1 (n=17, 121)	15.69 (26.66)	18.46 (29.17)
Financial Difficulties: C15D1 (n=15, 113)	6.67 (18.69)	18.29 (28.86)
Financial Difficulties: C16D1 (n=12, 109)	13.89 (30.01)	18.65 (29.20)
Financial Difficulties: C17D1 (n=11, 98)	15.15 (22.92)	18.37 (27.55)
Financial Difficulties: C18D1 (n=10, 92)	10.00 (22.50)	19.57 (28.45)
Financial Difficulties: C19D1 (n=9, 84)	3.70 (11.11)	19.05 (28.94)
Financial Difficulties: C20D1 (n=9, 80)	11.11 (33.33)	18.75 (27.99)
Financial Difficulties: C21D1 (n=9, 75)	11.11 (33.33)	23.11 (30.99)
Financial Difficulties: C22D1 (n=8, 68)	12.50 (35.36)	18.63 (28.44)
Financial Difficulties: C23D1 (n=7, 66)	9.52 (25.20)	21.72 (30.66)
Financial Difficulties: C24D1 (n=5, 64)	13.33 (29.81)	20.83 (29.99)
Financial Difficulties: C25D1 (n=3, 60)	0.00 (0.00)	21.67 (31.19)
Financial Difficulties: C26D1 (n=3, 55)	0.00 (0.00)	20.00 (30.50)
Financial Difficulties: C27D1 (n=3, 52)	0.00 (0.00)	17.31 (28.38)
Financial Difficulties: C28D1 (n=1, 48)	0.00 [2] (NA)	18.06 (26.59)
Financial Difficulties: C29D1 (n=2, 40)	50.00 (70.71)	19.17 (28.13)
Financial Difficulties: C30D1 (n=1, 31)	0.00 [2] (NA)	17.20 (25.63)
Financial Difficulties: C31D1(n=0, 24)	NA [3] (NA)	20.83 (25.66)
Financial Difficulties: C32D1(n=0, 22)	NA [3] (NA)	21.21 (26.32)
Financial Difficulties: C33D1(n=0, 16)	NA [3] (NA)	22.92 (29.11)
Financial Difficulties: C34D1(n=0, 14)	NA [3] (NA)	26.19 (35.03)
Financial Difficulties: C35D1(n=0, 12)	NA [3] (NA)	27.78 (37.15)
Financial Difficulties: C36D1(n=0, 8)	NA [3] (NA)	8.33 (15.43)
Financial Difficulties: C37D1(n=0, 5)	NA [3] (NA)	26.67 (43.46)
Financial Difficulties: C38D1(n=0, 2)	NA [3] (NA)	16.67 (23.57)
Financial Difficulties: EOT(n=263, 245)	21.80 (29.23)	19.46 (28.75)
Financial Difficulties: Pro Week 6 Pd (n=0, 1)	NA [3] (NA)	33.33 [2] (NA)
Financial Difficulties:Survival FU-1 (n=2,24)	83.33 (23.57)	66.67 [2] (NA)
Insomnia: Baseline (n= 388, 413)	28.87 (30.55)	26.15 (28.72)
Insomnia: C2D1(n= 340, 367)	27.55 (30.87)	26.52 (28.61)
Insomnia: C3D1(n= 253, 304)	25.69 (29.15)	24.89 (27.32)
Insomnia: C4D1(n= 222, 279)	21.32 (26.07)	23.66 (26.48)
Insomnia: C5D1(n= 166, 237)	21.49 (25.43)	25.88 (29.84)
Insomnia: C6D1(n= 150, 225)	22.00 (26.71)	23.41 (27.73)
Insomnia: C7D1(n= 87, 189)	21.07 (25.47)	23.99 (26.65)
Insomnia: C8D1(n= 70, 169)	15.24 (23.87)	23.87 (26.27)
Insomnia: C9D1(n= 49, 153)	16.33 (26.46)	22.88 (27.16)
Insomnia: C10D1(n= 46, 144)	13.77 (19.34)	21.53 (26.87)
Insomnia: C11D1(n= 36, 133)	9.26 (18.87)	20.55 (27.44)
Insomnia: C12D1(n= 29, 132)	16.09 (30.37)	21.46 (24.41)
Insomnia: C13D1(n= 17, 124)	17.65 (29.15)	23.39 (28.51)
Insomnia: C14D1(n= 17, 121)	25.49 (27.71)	23.69 (26.33)
Insomnia: C15D1(n= 15, 113)	22.22 (29.99)	21.53 (28.84)
Insomnia: C16D1(n= 13, 108)	20.51 (25.60)	21.60 (31.01)
Insomnia: C17D1(n= 11, 98)	21.21 (26.97)	20.07 (28.21)
Insomnia: C18D1(n= 10, 92)	20.00 (32.20)	21.38 (27.77)
Insomnia: C19D1(n= 9, 83)	18.52 (24.22)	22.49 (28.09)
Insomnia: C20D1(n= 9, 80)	18.52 (33.79)	20.83 (29.71)
Insomnia: C21D1(n= 9, 75)	22.22 (33.33)	20.89 (29.90)
Insomnia: C22D1(n= 8, 69)	16.67 (35.63)	18.84 (26.49)
Insomnia: C23D1(n= 8, 66)	20.83 (35.36)	19.70 (28.03)
Insomnia: C24D1(n= 5, 64)	26.67 (27.89)	19.79 (25.00)
Insomnia: C25D1(n= 3, 60)	11.11 (19.24)	18.89 (23.26)
Insomnia: C26D1(n= 3, 55)	11.11 (19.24)	21.21 (27.49)
Insomnia: C27D1(n= 3, 52)	11.11 (19.24)	19.23 (28.27)
Insomnia: C28D1(n= 1, 49)	0.00 [2] (NA)	21.09 (27.80)
Insomnia: C29D1(n= 2, 40)	33.33 (47.14)	21.67 (26.74)
Insomnia: C30D1(n= 1, 31)	0.00 [2] (NA)	20.43 (28.12)
Insomnia: C31D1(n= 0, 24)	NA [3] (NA)	20.83 (27.47)
Insomnia: C32D1(n= 0, 22)	NA [3] (NA)	19.70 (26.55)
Insomnia: C33D1(n= 0, 16)	NA [3] (NA)	20.83 (34.16)
Insomnia: C34D1(n= 0, 14)	NA [3] (NA)	23.81 (24.21)
Insomnia: C35D1(n= 0, 12)	NA [3] (NA)	25.00 (28.87)
Insomnia: C36D1(n= 0, 8)	NA [3] (NA)	25.00 (23.57)
Insomnia: C37D1(n= 0, 5)	NA [3] (NA)	33.33 (23.57)
Insomnia: C38D1(n= 0, 2)	NA [3] (NA)	16.67 (23.57)
Insomnia: EOT(n= 264, 246)	28.91 (30.65)	29.95 (30.30)
Insomnia: Pro Week Pd(n= 0, 1)	NA [3] (NA)	66.67 [2] (NA)
Insomnia: Survival FU-1 (n= 2, 1)	50.00 (70.71)	100.00 [2] (NA)
Dyspnea: C1D1 (n= 389, 412)	33.50 (31.11)	32.04 (28.73)
Dyspnea: C2D1 (n= 341, 368)	32.55 (29.03)	31.88 (29.70)
Dyspnea: C3D1 (n= 255, 302)	29.93 (27.54)	27.15 (26.73)
Dyspnea: C4D1 (n= 389, 277)	28.38 (24.37)	28.28 (27.48)
Dyspnea: C5D1 (n= 222, 236)	29.52 (24.46)	27.82 (27.03)
Dyspnea: C6D1 (n= 166, 222)	30.02 (26.32)	26.88 (25.63)
Dyspnea: C7D1 (n= 151, 188)	27.13 (25.31)	25.53 (25.99)
Dyspnea: C8D1 (n= 86, 169)	28.70 (29.76)	26.43 (26.70)
Dyspnea: C9D1 (n= 72, 152)	26.67 (28.57)	24.12 (24.92)
Dyspnea: C10D1 (n= 50, 146)	27.66 (28.93)	23.52 (23.54)
Dyspnea: C11D1 (n= 47, 134)	25.23 (30.84)	22.89 (25.00)
Dyspnea: C12D1 (n= 37, 132)	26.67 (26.84)	22.73 (25.83)
Dyspnea: C13D1 (n= 30, 123)	19.30 (23.08)	25.47 (26.68)
Dyspnea: C14D1 (n= 19, 119)	20.37 (25.92)	21.85 (25.47)
Dyspnea: C15D1 (n= 16, 113)	16.67 (17.21)	22.71 (24.51)
Dyspnea: C16D1 (n= 13, 109)	20.51 (16.88)	21.71 (25.00)
Dyspnea: C17D1 (n= 11, 98)	15.15 (17.41)	21.43 (23.57)
Dyspnea: C18D1 (n= 10, 92)	20.00 (17.21)	22.83 (25.64)
Dyspnea: C19D1 (n= 9, 84)	11.11 (16.67)	23.41 (23.59)
Dyspnea: C20D1 (n= 9, 80)	18.52 (17.57)	21.67 (24.36)
Dyspnea: C21D1 (n= 9, 75)	18.52 (17.57)	19.11 (20.63)
Dyspnea: C22D1 (n= 8, 68)	20.83 (35.36)	20.59 (23.06)
Dyspnea: C23D1 (n= 8, 65)	12.50 (17.25)	18.46 (21.27)
Dyspnea: C24D1 (n= 5, 64)	6.67 (14.91)	19.79 (24.28)
Dyspnea: C25D1 (n= 3, 60)	11.11 (19.24)	20.00 (22.30)
Dyspnea: C26D1 (n= 3, 55)	0.00 (0.00)	20.00 (24.51)
Dyspnea: C27D1 (n= 3, 52)	0.00 (0.00)	16.03 (19.23)
Dyspnea: C28D1 (n= 1, 49)	0.00 [2] (NA)	17.01 (20.55)
Dyspnea: C29D1 (n= 2, 40)	33.33 (47.14)	15.00 (21.28)
Dyspnea: C30D1 (n= 1, 31)	0.00 [2] (NA)	16.13 (18.99)
Dyspnea: C31D1 (n= 0, 24)	NA [3] (NA)	22.22 (23.40)
Dyspnea: C32D1 (n= 0, 22)	NA [3] (NA)	22.73 (21.54)
Dyspnea: C33D1 (n= 0, 16)	NA [3] (NA)	25.00 (31.03)
Dyspnea: C34D1 (n= 0, 14)	NA [3] (NA)	26.19 (26.73)
Dyspnea: C35D1 (n= 0, 12)	NA [3] (NA)	25.00 (25.13)
Dyspnea: C36D1 (n= 0, 8)	NA [3] (NA)	20.83 (17.25)
Dyspnea: C37D1 (n= 0, 5)	NA [3] (NA)	26.67 (14.91)
Dyspnea: C38D1 (n= 0, 2)	NA [3] (NA)	33.33 (0.00)
Dyspnea: EOT(n= 266, 247)	38.72 (30.51)	39.41 (32.57)
Dyspnea: Pro Week 6 Pd (n= 0, 1)	NA [3] (NA)	33.33 [2] (NA)
Dyspnea: Survival Follow-Up 1 (n= 2, 1)	33.33 (47.14)	33.33 [2] (NA)

[1]

Data not reported because standard deviation (SD) was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[3]

Data not reported because no participant was evaluated for this category

22. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Cognitive: Baseline (n= 390, 411)	83.38 (20.68)	85.16 (19.16)
Cognitive: C2D1 (n= 341, 363)	83.38 (21.64)	84.94 (19.30)
Cognitive: C3D1(n= 256, 305)	84.05 (19.82)	86.28 (17.32)
Cognitive: C4D1(n= 224, 281)	84.82 (19.27)	85.35 (19.87)
Cognitive: C5D1(n= 166, 238)	86.04 (17.24)	84.38 (19.73)
Cognitive: C6D1(n= 151, 224)	86.09 (18.20)	84.45 (20.27)
Cognitive: C7D1(n= 87, 189)	87.55 (16.32)	84.74 (18.93)
Cognitive: C8D1(n= 72, 171)	89.58 (13.83)	85.58 (18.87)
Cognitive: C9D1(n= 50, 153)	90.00 (14.29)	85.95 (18.65)
Cognitive: C10D1(n= 47, 146)	91.13 (11.96)	86.53 (19.31)
Cognitive: C11D1(n= 36, 134)	92.59 (10.87)	85.95 (19.91)
Cognitive: C12D1(n= 30, 132)	91.11 (12.17)	84.22 (20.52)
Cognitive: C13D1(n= 18, 124)	90.74 (11.75)	84.27 (21.50)
Cognitive: C14D1(n= 17, 121)	92.16 (11.96)	85.67 (18.30)
Cognitive: C15D1(n= 15, 113)	93.33 (10.54)	85.10 (19.08)
Cognitive: C16D1(n= 12, 109)	97.22 (6.49)	85.32 (21.12)
Cognitive: C17D1(n= 11, 98)	96.97 (6.74)	85.37 (20.48)
Cognitive: C18D1(n= 10, 92)	91.67 (11.79)	82.97 (20.52)
Cognitive: C19D1(n= 9, 84)	92.59 (12.11)	83.53 (20.12)
Cognitive: C20D1(n= 9, 80)	90.74 (14.70)	82.29 (22.87)
Cognitive: C21D1(n= 9, 75)	87.04 (23.24)	83.78 (20.32)
Cognitive: C22D1(n= 8, 68)	89.58 (12.40)	84.56 (21.03)
Cognitive: C23D1(n= 8, 66)	95.83 (7.72)	84.09 (20.55)
Cognitive: C24D1(n= 5, 64)	83.33 (23.57)	83.85 (23.56)
Cognitive: C25D1(n= 3, 60)	72.22 (25.46)	83.61 (21.59)
Cognitive: C26D1(n= 3, 55)	77.78 (19.24)	82.73 (21.51)
Cognitive: C27D1(n= 3, 52)	88.89 (19.24)	85.26 (20.25)
Cognitive: C28D1(n= 1, 48)	100.00 [1] (NA)	85.07 (20.98)
Cognitive: C29D1(n= 2, 40)	50.00 (70.71)	83.75 (20.84)
Cognitive: C30D1(n= 1, 31)	100.00 [1] (NA)	86.02 (20.68)
Cognitive: C31D1(n= 0, 24)	NA [2] (NA)	80.56 (21.23)
Cognitive: C32D1(n= 0, 22)	NA [2] (NA)	82.58 (22.11)
Cognitive: C33D1(n= 0,16)	NA [2] (NA)	77.08 (25.73)
Cognitive: C34D1(n= 0, 14)	NA [2] (NA)	80.95 (24.33)
Cognitive: C35D1(n= 0, 12)	NA [2] (NA)	76.39 (21.86)
Cognitive: C36D1(n= 0, 8)	NA [2] (NA)	83.33 (15.43)
Cognitive: C37D1(n= 0, 5)	NA [2] (NA)	83.33 (16.67)
Cognitive: C38D1(n= 0, 2)	NA [2] (NA)	91.67 (11.79)
Cognitive: EOT (n= 266, 246)	78.82 (24.54)	78.52 (22.50)
Cognitive: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	83.33 [1] (NA)
Cognitive: Survival FU 1 (n= 2, 1)	50.00 (47.14)	0.00 [1] (NA)
Emotional: Baseline (n= 390, 411)	75.83 (22.59)	76.55 (21.77)
Emotional: C2D1(n= 341, 363)	78.06 (22.63)	79.47 (20.72)
Emotional: C3D1(n= 256, 305)	79.70 (22.24)	82.71 (17.45)
Emotional: C4D1(n= 224, 280)	81.67 (20.36)	83.69 (17.70)
Emotional: C5D1(n= 166, 238)	80.52 (20.24)	81.99 (19.22)
Emotional: C6D1(n= 151, 224)	81.73 (20.50)	82.70 (19.91)
Emotional: C7D1(n= 87, 189)	81.42 (22.00)	83.77 (17.71)
Emotional: C8D1(n= 72, 171)	84.38 (18.66)	83.63 (19.40)
Emotional: C9D1(n= 50, 153)	86.00 (17.93)	85.62 (18.72)
Emotional: C10D1(n= 47, 146)	84.93 (17.69)	84.13 (19.74)
Emotional: C11D1(n= 36, 134)	89.12 (15.15)	84.16 (18.14)
Emotional: C12D1(n= 30, 132)	86.94 (14.79)	84.34 (20.10)
Emotional: C13D1(n= 18, 123)	89.35 (14.52)	84.35 (19.75)
Emotional: C14D1(n= 17, 121)	86.27 (15.57)	84.25 (19.11)
Emotional: C15D1(n= 15, 113)	90.00 (14.16)	83.87 (20.04)
Emotional: C16D1(n= 12, 109)	88.89 (16.02)	82.11 (22.59)
Emotional: C17D1(n= 11, 98)	88.64 (17.59)	83.25 (19.50)
Emotional: C18D1(n= 10, 92)	87.50 (19.35)	82.52 (21.11)
Emotional: C19D1(n= 9, 84)	87.96 (19.14)	81.42 (20.55)
Emotional: C20D1(n=9, 80)	76.85 (34.30)	83.19 (18.90)
Emotional: C21D1(n= 9, 75)	83.33 (26.68)	84.19 (17.58)
Emotional: C22D1(n= 8, 68)	76.74 (32.60)	86.03 (16.44)
Emotional: C23D1(n= 8, 66)	89.58 (15.91)	87.00 (17.55)
Emotional: C24D1(n=5, 65)	78.33 (33.12)	83.72 (19.18)
Emotional: C25D1(n= 3, 60)	100.00 (0.00)	83.66 (18.77)
Emotional: C26D1(n= 3, 55)	86.11 (12.73)	85.15 (19.69)
Emotional: C27D1(n= 3, 52)	100.00 (0.00)	86.38 (18.38)
Emotional: C28D1(n= 1, 48)	100.00 [1] (NA)	86.92 (17.51)
Emotional: C29D1(n= 2, 40)	50.00 (70.71)	87.50 (16.45)
Emotional: C30D1(n= 1, 31)	100.00 [1] (NA)	89.79 (15.62)
Emotional: C31D1(n= 0, 24)	NA [2] (NA)	85.76 (18.30)
Emotional: C32D1(n= 0, 22)	NA [2] (NA)	82.95 (20.81)
Emotional: C33D1(n= 0, 16)	NA [2] (NA)	81.25 (25.37)
Emotional: C34D1(n= 0, 14)	NA [2] (NA)	82.14 (25.29)
Emotional: C35D1(n= 0, 12)	NA [2] (NA)	83.33 (21.61)
Emotional: C36D1(n= 0, 8)	NA [2] (NA)	95.83 (11.78)
Emotional: C37D1(n= 0, 5)	NA [2] (NA)	90.00 (14.91)
Emotional: C38D1(n= 0, 2)	NA [2] (NA)	83.33 (23.57)
Emotional: EOT (n= 265, 246)	73.78 (26.29)	73.92 (23.74)
Emotional: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	66.67 [1] (NA)
Emotional: Survival FU-1 (n= 2,1)	25.00 (35.36)	33.33 [1] (NA)
Physical: Baseline (n= 390, 413)	73.27 (22.58)	74.46 (20.66)
Physical: C2D1(n= 343, 369)	72.64 (22.00)	71.70 (22.49)
Physical: C3D1(n= 255, 304)	74.98 (21.60)	76.19 (19.48)
Physical: C4D1(n= 224, 277)	75.72 (19.05)	76.79 (19.95)
Physical: C5D1(n= 167, 238)	77.30 (19.00)	77.79 (19.89)
Physical: C6D1(n= 151, 225)	74.77 (19.26)	78.93 (18.76)
Physical: C7D1(n= 88, 189)	77.61 (18.08)	79.20 (18.42)
Physical: C8D1(n= 71, 170)	78.45 (17.72)	78.87 (18.91)
Physical: C9D1(n= 50, 153)	79.07 (20.43)	79.46 (18.75)
Physical: C10D1(n= 47, 146)	79.29 (19.96)	79.41 (18.85)
Physical: C11D1(n= 37, 134)	81.44 (20.85)	79.09 (20.50)
Physical: C12D1(n= 30, 132)	82.22 (15.69)	79.72 (18.84)
Physical: C13D1(n= 19, 124)	87.37 (9.66)	80.48 (19.33)
Physical: C14D1(n= 18, 121)	85.56 (9.50)	80.33 (17.55)
Physical: C15D1(n= 16, 113)	86.25 (8.24)	79.88 (18.64)
Physical: C16D1(n= 13, 109)	85.13 (9.49)	78.82 (21.32)
Physical: C17D1(n= 11, 98)	84.24 (12.03)	78.57 (20.89)
Physical: C18D1(n= 10, 92)	82.67 (13.03)	79.64 (19.92)
Physical: C19D1(n= 9, 84)	87.41 (10.77)	78.97 (20.48)
Physical: C20D1(n= 9, 80)	81.48 (18.19)	79.19 (20.26)
Physical: C21D1(n= 9, 75)	87.41 (11.28)	78.67 (20.68)
Physical: C22D1(n= 8, 69)	82.50 (19.82)	82.51 (16.92)
Physical: C23D1(n= 8, 66)	85.00 (13.21)	80.81 (17.56)
Physical: C24D1(n= 5, 64)	80.00 (18.26)	81.41 (17.69)
Physical: C25D1(n= 3, 60)	82.22 (16.78)	83.22 (16.67)
Physical: C26D1(n= 3, 55)	75.56 (3.85)	80.12 (17.43)
Physical: C27D1(n= 2, 52)	76.67 (4.71)	81.89 (16.90)
Physical: C28D1(n= 2, 49)	65.00 (21.21)	84.15 (14.41)
Physical: C29D1(n= 2, 40)	56.67 (33.00)	83.00 (14.87)
Physical: C30D1(n= 1, 31)	80.00 [1] (NA)	83.01 (15.67)
Physical: C31D1(n= 0, 24)	NA [2] (NA)	78.61 (17.25)
Physical: C32D1(n= 0, 22)	NA [2] (NA)	75.15 (18.42)
Physical: C33D1(n= 0, 16)	NA [2] (NA)	77.92 (17.84)
Physical: C34D1(n= 0, 14)	NA [2] (NA)	75.24 (19.47)
Physical: C35D1(n= 0, 12)	NA [2] (NA)	73.89 (20.78)
Physical: C36D1(n= 0, 8)	NA [2] (NA)	83.33 (17.46)
Physical: C37D1(n= 0, 5)	NA [2] (NA)	74.67 (14.45)
Physical: C38D1(n= 0, 2)	NA [2] (NA)	86.67 (0.00)
Physical: EOT(n= 267, 246)	63.59 (24.57)	64.78 (26.47)
Physical: Pro Week 6 Pd(n= 0, 1)	NA [2] (NA)	46.67 [1] (NA)
Physical: Survival FU-1 (n= 2, 1)	36.67 (51.85)	46.67 [1] (NA)
Role: Baseline (n=388, 413)	70.92 (30.68)	73.61 (29.13)
Role: C2D1 (n=339, 369)	69.91 (29.89)	68.29 (31.50)
Role: C3D1 (n=256, 304)	74.61 (27.21)	75.27 (27.28)
Role: C4D1 (n=224, 279)	73.36 (26.22)	76.70 (25.27)
Role: C5D1 (n=167, 238)	74.35 (25.00)	76.05 (26.97)
Role: C6D1 (n=151, 225)	73.62 (26.62)	77.70 (26.78)
Role: C7D1 (n=88, 190)	77.27 (23.19)	79.04 (24.97)
Role: C8D1 (n=72, 170)	73.61 (26.50)	77.35 (25.22)
Role: C9D1 (n=50, 153)	77.67 (24.42)	79.30 (25.36)
Role: C10D1 (n=47, 145)	78.72 (27.74)	81.38 (24.34)
Role: C11D1 (n=37, 134)	80.63 (24.69)	78.61 (27.01)
Role: C12D1 (n=30, 132)	81.11 (22.20)	79.80 (25.97)
Role: C13D1 (n=19, 124)	84.21 (18.82)	79.44 (26.55)
Role: C14D1 (n=18, 121)	78.70 (21.24)	79.48 (24.98)
Role: C15D1 (n=16, 113)	83.33 (14.91)	79.20 (25.05)
Role: C16D1 (n=13, 109)	85.90 (19.06)	76.45 (27.89)
Role: C17D1 (n=11, 98)	80.30 (20.84)	76.02 (29.22)
Role: C18D1 (n=10, 92)	80.00 (26.99)	77.17 (27.59)
Role: C19D1 (n=9, 84)	85.19 (22.74)	78.17 (28.46)
Role: C20D1 (n=9, 80)	79.63 (29.79)	78.54 (26.01)
Role: C21D1 (n=9, 75)	85.19 (15.47)	77.33 (28.29)
Role: C22D1 (n=8, 69)	79.17 (35.36)	81.64 (26.68)
Role: C23D1 (n=8, 66)	85.42 (20.77)	80.30 (26.13)
Role: C24D1 (n=5, 65)	70.00 (34.16)	78.72 (26.92)
Role: C25D1 (n=3, 60)	77.78 (38.49)	79.44 (27.34)
Role: C26D1 (n=3, 55)	83.33 (28.87)	76.97 (27.31)
Role: C27D1 (n=3, 52)	88.89 (19.24)	80.77 (26.89)
Role: C28D1 (n=1, 49)	100.00 [1] (NA)	82.99 (22.69)
Role: C29D1 (n=2, 40)	66.67 (47.14)	83.33 (24.75)
Role: C30D1 (n=1, 31)	100.00 [1] (NA)	81.72 (24.10)
Role: C31D1(n=0, 24)	NA [2] (NA)	79.86 (25.53)
Role: C32D1(n=0, 22)	NA [2] (NA)	75.00 (27.58)
Role: C33D1(n=0, 16)	NA [2] (NA)	66.67 (34.43)
Role: C34D1(n=0, 14)	NA [2] (NA)	69.05 (33.88)
Role: C35D1(n=0, 12)	NA [2] (NA)	69.44 (32.44)
Role: C36D1(n=0, 8)	NA [2] (NA)	87.50 (17.25)
Role: C37D1(n=0, 5)	NA [2] (NA)	76.67 (22.36)
Role: C38D1(n=0, 2)	NA [2] (NA)	100.00 (0.00)
Role: EOT(n=266, 246)	58.52 (32.99)	60.03 (33.25)
Role: Pro Week 6 Pd (n=0, 1)	NA [2] (NA)	66.67 [1] (NA)
Role: Survival FU-1 (n=2,1)	33.33 (47.14)	33.33 [1] (NA)
Social: Baseline (n= 389, 411)	74.16 (26.92)	77.41 (26.13)
Social: C2D1(n= 340, 363)	74.51 (26.50)	76.86 (26.25)
Social: C3D1(n= 255, 305)	78.37 (25.30)	81.15 (23.70)
Social: C4D1(n= 223, 280)	79.60 (23.00)	81.31 (24.15)
Social: C5D1(n= 166, 238)	79.32 (22.26)	82.00 (24.39)
Social: C6D1(n= 151, 224)	78.15 (24.05)	81.99 (23.80)
Social: C7D1(n= 87, 189)	80.65 (22.57)	82.80 (22.54)
Social: C8D1(n= 72, 171)	81.94 (22.16)	81.19 (23.95)
Social: C9D1(n= 50, 153)	82.00 (22.80)	83.77 (22.29)
Social: C10D1(n= 47, 146)	81.21 (24.97)	83.79 (22.99)
Social: C11D1(n= 36, 134)	82.41 (26.11)	81.47 (25.42)
Social: C12D1(n= 30, 132)	86.67 (18.77)	82.95 (24.58)
Social: C13D1(n= 18, 124)	89.81 (15.27)	84.27 (22.82)
Social: C14D1(n= 17, 121)	86.27 (19.75)	84.16 (22.55)
Social: C15D1(n= 15, 113)	93.33 (13.80)	83.92 (22.26)
Social: C16D1(n= 12, 109)	84.72 (16.60)	82.72 (24.73)
Social: C17D1(n= 11, 98)	87.88 (16.82)	82.99 (23.57)
Social: C18D1(n= 10, 92)	86.67 (17.21)	81.34 (24.06)
Social: C19D1(n= 9, 84)	88.89 (16.67)	81.94 (25.90)
Social: C20D1(n= 9, 80)	81.48 (33.79)	81.46 (24.73)
Social: C21D1(n= 9, 75)	85.19 (24.22)	78.67 (27.88)
Social: C22D1(n= 8, 68)	85.42 (30.13)	84.31 (25.41)
Social: C23D1(n= 8, 66)	91.67 (15.43)	80.56 (26.24)
Social: C24D1(n= 5, 65)	80.00 (27.39)	80.77 (25.38)
Social: C25D1(n= 3, 60)	77.78 (38.49)	81.39 (27.80)
Social: C26D1(n= 3, 55)	77.78 (19.24)	79.70 (27.53)
Social: C27D1(n= 3, 52)	88.89 (19.24)	82.05 (25.32)
Social: C28D1(n= 1, 48)	100.00 [1] (NA)	84.03 (24.30)
Social: C29D1(n= 2, 40)	50.00 (70.71)	82.92 (24.60)
Social: C30D1(n= 1, 31)	100.00 [1] (NA)	79.57 (27.79)
Social: C31D1(n= 0, 24)	NA [2] (NA)	79.17 (26.12)
Social: C32D1(n= 0, 22)	NA [2] (NA)	73.48 (30.71)
Social: C33D1(n= 0, 16)	NA [2] (NA)	73.96 (32.19)
Social: C34D1(n= 0, 14)	NA [2] (NA)	67.86 (34.88)
Social: C35D1(n= 0, 12)	NA [2] (NA)	70.83 (31.88)
Social: C36D1(n= 0, 8)	NA [2] (NA)	87.50 (17.25)
Social: C37D1(n= 0, 5)	NA [2] (NA)	80.00 (18.26)
Social: C38D1(n= 0, 2)	NA [2] (NA)	100.00 (0.00)
Social: EOT(n= 264, 245)	69.51 (30.65)	70.00 (30.05)
Social: Pro Week 6 Pd(n= 0, 1)	NA [2] (NA)	66.67 [1] (NA)
Social: Survival FU-1 (n= 2, 1)	83.33 (23.57)	16.67 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

23. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: GHS Scale
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Global Health: Baseline (n= 387, 410)	60.55 (22.25)	61.24 (22.31)
Global Health: C2D1(n= 339, 361)	59.56 (22.15)	58.93 (23.57)
Global Health: C3D1(n= 255, 304)	64.64 (18.66)	64.61 (20.74)
Global Health: C4D1(n= 222, 279)	63.51 (20.67)	65.11 (21.36)
Global Health: C5D1(n= 166, 235)	64.01 (18.37)	66.35 (19.84)
Global Health: C6D1(n= 151, 223)	64.51 (19.59)	65.73 (21.42)
Global Health: C7D1(n= 87, 187)	64.85 (18.13)	66.93 (19.61)
Global Health: C8D1(n= 72, 169)	62.73 (20.22)	67.36 (19.45)
Global Health: C9D1(n= 50, 152)	67.17 (18.93)	68.09 (19.46)
Global Health: C10D1(n= 47, 145)	66.84 (18.67)	69.37 (20.90)
Global Health: C11D1(n= 36, 133)	69.68 (17.15)	68.17 (21.24)
Global Health: C12D1(n= 30, 131)	66.67 (18.05)	68.32 (20.42)
Global Health: C13D1(n= 18, 124)	69.91 (14.33)	67.74 (22.52)
Global Health: C14D1(n= 17, 120)	69.61 (14.71)	67.01 (20.62)
Global Health: C15D1(n= 15, 113)	69.44 (17.16)	68.66 (20.21)
Global Health: C16D1(n= 12, 109)	62.50 (15.69)	67.97 (21.67)
Global Health: C17D1(n= 10, 98)	61.67 (19.72)	68.62 (19.84)
Global Health: C18D1(n= 10, 92)	61.67 (21.23)	68.57 (18.86)
Global Health: C19D1(n= 9, 84)	65.74 (21.43)	68.25 (20.10)
Global Health: C20D1(n= 9, 80)	62.04 (26.72)	68.12 (20.10)
Global Health: C21D1(n= 9, 75)	60.19 (29.98)	66.56 (21.55)
Global Health: C22D1(n= 8, 68)	54.17 (24.80)	73.28 (17.13)
Global Health: C23D1(n= 8, 66)	62.50 (19.42)	70.45 (18.09)
Global Health: C24D1(n= 5, 65)	70.00 (27.39)	69.36 (19.27)
Global Health: C25D1(n= 3, 60)	66.67 (28.87)	69.03 (19.23)
Global Health: C26D1(n= 3, 55)	66.67 (28.87)	68.64 (20.60)
Global Health: C27D1(n= 3, 52)	66.67 (28.87)	68.91 (21.84)
Global Health: C28D1(n= 2, 48)	87.50 (17.68)	71.87 (20.60)
Global Health: C29D1(n= 2, 40)	91.67 (11.79)	72.71 (20.06)
Global Health: C30D1(n= 1, 30)	83.33 [1] (NA)	75.28 (18.63)
Global Health: C31D1(n= 0, 24)	NA [2] (NA)	71.53 (21.13)
Global Health: C32D1(n= 0, 22)	NA [2] (NA)	70.45 (20.21)
Global Health: C33D1(n= 0,16)	NA [2] (NA)	67.19 (27.30)
Global Health: C34D1(n= 0, 14)	NA [2] (NA)	68.45 (26.19)
Global Health: C35D1(n= 0, 12)	NA [2] (NA)	69.44 (26.43)
Global Health: C36D1(n= 0, 8)	NA [2] (NA)	80.21 (16.63)
Global Health: C37D1(n= 0, 5)	NA [2] (NA)	76.67 (19.00)
Global Health: C38D1(n= 0, 2)	NA [2] (NA)	91.67 (11.79)
Global Health: EOT(n= 262, 245)	51.69 (24.02)	52.82 (24.48)
Global Health: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	50.00 [1] (NA)
Global Health: Survival FU 1 (n= 2, 1)	58.33 (35.36)	33.33 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

24. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Nausea/Vomiting: Baseline (n= 389, 413)	8.01 (16.34)	7.59 (16.35)
Nausea/Vomiting: C2D1(n= 342, 369)	11.50 (19.30)	9.53 (17.25)
Nausea/Vomiting: C3D1(n= 253, 305)	7.05 (15.06)	7.27 (15.32)
Nausea/Vomiting: C4D1(n= 223, 279)	7.40 (14.37)	7.17 (15.50)
Nausea/Vomiting: C5D1(n= 167, 238)	6.29 (12.49)	6.44 (14.54)
Nausea/Vomiting: C6D1(n= 151, 225)	6.40 (13.17)	6.44 (15.16)
Nausea/Vomiting: C7D1(n= 88, 190)	6.82 (13.28)	5.61 (13.74)
Nausea/Vomiting: C8D1(n= 72, 170)	6.02 (12.91)	4.61 (10.57)
Nausea/Vomiting: C9D1(n= 50, 153)	3.33 (8.91)	2.83 (8.06)
Nausea/Vomiting: C10D1(n= 47, 146)	2.48 (6.93)	3.54 (10.02)
Nausea/Vomiting: C11D1(n= 37, 134)	3.15 (6.62)	3.23 (8.54)
Nausea/Vomiting: C12D1(n= 30, 132)	3.89 (8.40)	3.03 (7.66)
Nausea/Vomiting: C13D1(n= 19, 124)	4.39 (9.37)	3.36 (10.19)
Nausea/Vomiting: C14D1(n= 18, 121)	4.63 (9.58)	3.31 (9.03)
Nausea/Vomiting: C15D1(n= 16, 113)	1.04 (4.17)	3.83 (11.14)
Nausea/Vomiting: C16D1(n= 13, 109)	5.13 (10.51)	2.75 (8.64)
Nausea/Vomiting: C17D1(n= 11, 98)	9.09 (13.67)	2.55 (8.06)
Nausea/Vomiting: C18D1(n= 10, 92)	6.67 (11.65)	3.08 (8.88)
Nausea/Vomiting: C19D1(n= 9, 84)	3.70 (7.35)	4.17 (11.53)
Nausea/Vomiting: C20D1(n= 9, 80)	5.56 (8.33)	3.13 (11.28)
Nausea/Vomiting: C21D1(n= 9, 75)	1.85 (5.56)	4.89 (13.08)
Nausea/Vomiting: C22D1(n= 8, 69)	6.25 (8.63)	1.93 (7.31)
Nausea/Vomiting: C23D1(n= 8, 66)	6.25 (12.40)	2.53 (6.69)
Nausea/Vomiting: C24D1(n= 5, 64)	0.00 (0.00)	2.34 (7.19)
Nausea/Vomiting: C25D1(n= 3, 60)	0.00 (0.00)	1.94 (6.21)
Nausea/Vomiting: C26D1(n= 3, 55)	0.00 (0.00)	2.73 (8.34)
Nausea/Vomiting: C27D1(n= 3, 52)	0.00 (0.00)	2.24 (6.62)
Nausea/Vomiting: C28D1(n= 1, 49)	0.00 [1] (NA)	1.02 (4.04)
Nausea/Vomiting: C29D1(n= 2, 40)	33.33 (47.14)	1.67 (5.06)
Nausea/Vomiting: C30D1(n= 1, 31)	0.00 [1] (NA)	1.61 (5.01)
Nausea/Vomiting: C31D1(n= 0, 24)	NA [2] (NA)	2.08 (5.63)
Nausea/Vomiting: C32D1(n= 0, 22)	NA [2] (NA)	1.52 (4.90)
Nausea/Vomiting: C33D1(n= 0,16)	NA [2] (NA)	1.04 (4.17)
Nausea/Vomiting: C34D1(n= 0, 14)	NA [2] (NA)	2.38 (8.91)
Nausea/Vomiting: C35D1(n= 0, 12)	NA [2] (NA)	1.39 (4.81)
Nausea/Vomiting: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Nausea/Vomiting: C37D1(n= 0, 5)	NA [2] (NA)	6.67 (9.13)
Nausea/Vomiting: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Nausea/Vomiting: EOT(n= 266, 245)	11.65 (20.11)	10.61 (17.62)
Nausea/Vomiting: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	16.67 [1] (NA)
Nausea/Vomiting: Survival FU 1 (n= 2, 1)	50.00 (70.71)	66.67 [1] (NA)
Pain: Baseline (n= 390, 413)	29.70 (29.45)	29.98 (29.72)
Pain: C2D1(n= 343, 368)	28.43 (27.24)	29.30 (29.03)
Pain: C3D1(n= 256, 305)	22.59 (24.93)	24.15 (27.50)
Pain: C4D1(n= 224, 280)	21.65 (24.48)	23.75 (25.84)
Pain: C5D1(n= 167, 239)	20.96 (22.55)	23.22 (25.41)
Pain: C6D1(n= 151, 225)	22.41 (21.95)	21.63 (24.68)
Pain: C7D1(n= 88, 190)	21.59 (22.34)	21.58 (25.30)
Pain: C8D1(n= 72, 171)	23.38 (22.49)	22.03 (24.36)
Pain: C9D1(n= 50, 153)	16.33 (20.89)	19.28 (23.50)
Pain: C10D1(n= 47, 146)	14.54 (17.93)	21.00 (24.61)
Pain: C11D1(n= 37, 134)	13.96 (22.05)	21.27 (26.60)
Pain: C12D1(n= 30, 132)	13.33 (21.17)	18.69 (24.71)
Pain: C13D1(n= 19, 124)	16.67 (25.46)	17.74 (21.23)
Pain: C14D1(n= 18, 120)	12.04 (15.97)	17.64 (22.17)
Pain: C15D1(n= 16, 113)	10.42 (17.08)	17.40 (22.86)
Pain: C16D1(n= 13, 109)	21.79 (21.93)	20.64 (25.25)
Pain: C17D1(n= 11, 98)	16.67 (19.72)	20.41 (25.39)
Pain: C18D1(n= 10, 92)	11.67 (22.29)	20.83 (24.54)
Pain: C19D1(n= 9, 84)	14.81 (22.74)	22.42 (28.16)
Pain: C20D1(n=9, 80)	27.78 (31.18)	20.00 (23.78)
Pain: C21D1(n= 9, 75)	14.81 (17.57)	19.78 (25.95)
Pain: C22D1(n= 8, 69)	18.75 (20.77)	15.22 (19.75)
Pain: C23D1(n= 8, 66)	14.58 (27.37)	16.92 (23.11)
Pain: C24D1(n=5, 64)	30.00 (36.13)	20.05 (25.05)
Pain: C25D1(n= 3, 60)	16.67 (28.87)	18.33 (22.90)
Pain: C26D1(n= 3, 55)	22.22 (19.24)	16.36 (21.87)
Pain: C27D1(n= 3, 52)	11.11 (19.24)	15.06 (20.41)
Pain: C28D1(n= 1, 49)	0.00 [1] (NA)	14.29 (18.63)
Pain: C29D1(n= 2, 40)	41.67 (58.93)	13.75 (18.06)
Pain: C30D1(n= 1, 31)	0.00 [1] (NA)	15.05 (21.24)
Pain: C31D1(n= 0, 24)	NA [2] (NA)	14.58 (21.03)
Pain: C32D1(n= 0, 22)	NA [2] (NA)	16.67 (24.67)
Pain: C33D1(n= 0, 16)	NA [2] (NA)	20.83 (27.55)
Pain: C34D1(n= 0, 14)	NA [2] (NA)	26.19 (27.51)
Pain: C35D1(n= 0, 12)	NA [2] (NA)	22.22 (25.95)
Pain: C36D1(n= 0, 8)	NA [2] (NA)	22.92 (34.43)
Pain: C37D1(n= 0, 5)	NA [2] (NA)	30.00 (34.16)
Pain: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Pain: EOT (n= 267, 247)	32.21 (30.36)	35.43 (31.22)
Pain: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	16.67 [1] (NA)
Pain: Survival FU-1 (n= 2,1)	66.67 (47.14)	83.33 [1] (NA)
Fatigue: Baseline (n= 390, 413)	37.59 (25.69)	36.21 (23.92)
Fatigue: C2D1(n= 343, 369)	40.52 (25.68)	39.78 (26.17)
Fatigue: C3D1(n= 256, 304)	35.29 (23.97)	33.90 (23.75)
Fatigue: C4D1(n= 224, 278)	35.59 (23.10)	30.72 (22.57)
Fatigue: C5D1(n= 167, 238)	36.03 (22.40)	30.95 (24.13)
Fatigue: C6D1(n= 151, 225)	36.28 (23.40)	28.89 (22.66)
Fatigue: C7D1(n= 88, 190)	34.34 (23.02)	28.33 (22.15)
Fatigue: C8D1(n= 72, 170)	30.86 (24.12)	27.97 (21.56)
Fatigue: C9D1(n= 50, 153)	28.67 (23.45)	25.78 (21.39)
Fatigue: C10D1(n= 47, 145)	29.31 (25.21)	26.32 (22.27)
Fatigue: C11D1(n= 37, 134)	27.63 (25.07)	25.62 (23.05)
Fatigue: C12D1(n= 30, 132)	28.89 (23.99)	26.60 (23.37)
Fatigue: C13D1(n= 19, 124)	22.22 (20.29)	27.51 (22.73)
Fatigue: C14D1(n= 18, 121)	21.60 (16.82)	26.31 (23.13)
Fatigue: C15D1(n= 16, 112)	20.14 (18.24)	27.73 (22.56)
Fatigue: C16D1(n= 13, 109)	21.79 (17.64)	27.22 (23.35)
Fatigue: C17D1(n= 11, 98)	22.22 (12.17)	27.21 (23.56)
Fatigue: C18D1(n= 10, 92)	26.67 (17.53)	27.29 (24.18)
Fatigue: C19D1(n= 9, 84)	22.22 (14.70)	27.65 (22.85)
Fatigue: C20D1(n= 9, 80)	32.10 (30.15)	25.21 (23.47)
Fatigue: C21D1(n= 9, 75)	28.39 (18.52)	26.44 (23.66)
Fatigue: C22D1(n= 8, 69)	33.33 (29.10)	22.38 (21.77)
Fatigue: C23D1(n= 8, 66)	25.00 (24.31)	24.16 (20.59)
Fatigue: C24D1(n= 5, 64)	31.11 (40.37)	23.78 (18.87)
Fatigue: C25D1(n= 3, 60)	11.11 (19.24)	23.89 (20.94)
Fatigue: C26D1(n= 3, 55)	18.52 (16.97)	28.69 (24.54)
Fatigue: C27D1(n= 3, 52)	11.11 (19.24)	22.65 (19.80)
Fatigue: C28D1(n= 1, 49)	0.00 [1] (NA)	22.34 (18.23)
Fatigue: C29D1(n= 2, 40)	44.44 (47.14)	21.11 (18.63)
Fatigue: C30D1(n= 1, 31)	22.22 [1] (NA)	23.66 (20.23)
Fatigue: C31D1(n= 0, 24)	NA [2] (NA)	23.15 (20.96)
Fatigue: C32D1(n= 0, 22)	NA [2] (NA)	25.25 (20.63)
Fatigue: C33D1(n= 0, 16)	NA [2] (NA)	29.86 (26.52)
Fatigue: C34D1(n= 0, 14)	NA [2] (NA)	31.75 (24.21)
Fatigue: C35D1(n= 0, 12)	NA [2] (NA)	25.00 (21.25)
Fatigue: C36D1(n= 0, 8)	NA [2] (NA)	16.67 (15.71)
Fatigue: C37D1(n= 0, 5)	NA [2] (NA)	24.44 (16.48)
Fatigue: C38D1(n= 0, 2)	NA [2] (NA)	16.67 (7.86)
Fatigue: EOT(n= 267, 246)	47.50 (26.72)	43.07 (28.15)
Fatigue: Pro Week 6 Pd(n= 0, 1)	NA [2] (NA)	44.44 [1] (NA)
Fatigue: Survival FU-1 (n= 2, 1)	83.33 (23.57)	88.89 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

25. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Alopecia
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Alopecia: Baseline (n= 384, 405)	13.89 (27.95)	14.32 (29.07)
Alopecia: C2D1(n= 332, 357)	60.44 (36.66)	6.63 (16.84)
Alopecia: C3D1(n= 248, 300)	56.72 (35.86)	7.44 (18.89)
Alopecia: C4D1(n= 219, 270)	52.36 (35.24)	7.41 (19.14)
Alopecia: C5D1(n= 163, 234)	56.65 (37.25)	6.41 (16.68)
Alopecia: C6D1(n= 147, 220)	54.42 (37.64)	7.88 (19.34)
Alopecia: C7D1(n= 87, 186)	52.11 (39.28)	5.91 (16.10)
Alopecia: C8D1(n= 70, 166)	48.57 (37.94)	6.63 (17.68)
Alopecia: C9D1(n= 47, 150)	48.23 (39.81)	5.11 (14.83)
Alopecia: C10D1(n= 45, 142)	49.63 (39.96)	3.76 (13.23)
Alopecia: C11D1(n= 36, 130)	47.22 (45.34)	3.08 (11.33)
Alopecia: C12D1(n= 29, 129)	36.78 (43.04)	4.91 (13.88)
Alopecia: C13D1(n= 19, 121)	42.11 (41.34)	6.06 (15.52)
Alopecia: C14D1(n= 18, 119)	29.63 (35.95)	5.60 (14.60)
Alopecia: C15D1(n= 16, 110)	33.33 (34.43)	7.27 (17.12)
Alopecia: C16D1(n= 12, 105)	27.78 (31.25)	7.30 (17.89)
Alopecia: C17D1(n= 11, 95)	21.21 (30.81)	9.47 (19.85)
Alopecia: C18D1(n= 9, 90)	22.22 (33.33)	8.89 (17.16)
Alopecia: C19D1(n= 8, 81)	25.00 (34.50)	10.29 (18.74)
Alopecia: C20D1(n= 9, 78)	44.44 (44.10)	8.55 (15.60)
Alopecia: C21D1(n= 9, 73)	22.22 (33.33)	9.59 (16.18)
Alopecia: C22D1(n= 7, 67)	9.52 (16.26)	9.45 (16.21)
Alopecia: C23D1(n= 8, 64)	29.17 (37.53)	11.46 (18.99)
Alopecia: C24D1(n= 5, 62)	13.33 (18.26)	8.06 (15.61)
Alopecia: C25D1(n= 2, 58)	0.00 (0.00)	9.77 (16.53)
Alopecia: C26D1(n= 2, 53)	0.00 (0.00)	9.43 (16.51)
Alopecia: C27D1(n= 3, 50)	33.33 (57.74)	9.33 (16.55)
Alopecia: C28D1(n= 2, 46)	0.00 (0.00)	6.52 (15.10)
Alopecia: C29D1(n= 2, 38)	0.00 (0.00)	8.77 (20.04)
Alopecia: C30D1(n= 1, 31)	0.00 [1] (NA)	10.75 (19.98)
Alopecia: C31D1(n= 0, 24)	NA [2] (NA)	9.72 (20.80)
Alopecia: C32D1(n= 0, 23)	NA [2] (NA)	7.25 (19.99)
Alopecia: C33D1(n= 0,16)	NA [2] (NA)	8.33 (22.77)
Alopecia: C34D1(n= 0, 14)	NA [2] (NA)	9.52 (20.38)
Alopecia: C35D1(n= 0, 11)	NA [2] (NA)	6.06 (13.48)
Alopecia: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Alopecia: C37D1(n= 0, 5)	NA [2] (NA)	6.67 (14.91)
Alopecia: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Alopecia: EOT(n= 261, 243)	53.51 (38.91)	6.58 (17.48)
Alopecia: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	100.00 [1] (NA)
Alopecia: Survival FU 1 (n= 2, 1)	100.00 (0.00)	66.67 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

26. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Coughing
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Coughing: Baseline (n= 383, 406)	38.73 (29.64)	37.27 (27.23)
Coughing: C2D1(n= 333, 360)	36.54 (28.04)	37.50 (28.33)
Coughing: C3D1(n= 250, 298)	33.73 (27.46)	33.89 (24.99)
Coughing: C4D1(n= 219, 272)	31.35 (24.13)	32.48 (25.52)
Coughing: C5D1(n= 164, 235)	32.72 (23.49)	31.35 (25.52)
Coughing: C6D1(n= 147, 219)	31.75 (24.78)	31.05 (24.73)
Coughing: C7D1(n= 87, 185)	32.95 (24.64)	30.99 (25.07)
Coughing: C8D1(n= 69, 166)	30.43 (28.43)	29.12 (25.73)
Coughing: C9D1(n= 50, 150)	24.67 (17.57)	29.11 (24.52)
Coughing: C10D1(n= 47, 140)	23.40 (19.55)	27.86 (22.83)
Coughing: C11D1(n= 37, 129)	21.62 (19.59)	27.39 (23.37)
Coughing: C12D1(n= 30, 129)	20.00 (18.77)	25.06 (23.95)
Coughing: C13D1(n= 19, 121)	15.79 (17.10)	24.79 (23.78)
Coughing: C14D1(n= 18, 119)	16.67 (17.15)	24.37 (22.42)
Coughing: C15D1(n= 16, 110)	12.50 (16.67)	25.76 (23.31)
Coughing: C16D1(n= 13, 106)	20.51 (21.68)	24.53 (22.21)
Coughing: C17D1(n= 11, 94)	21.21 (16.82)	24.82 (23.92)
Coughing: C18D1(n= 10, 90)	26.67 (21.08)	26.30 (24.22)
Coughing: C19D1(n= 9, 82)	22.22 (16.67)	25.61 (26.86)
Coughing: C20D1(n= 9, 78)	25.93 (14.70)	28.21 (26.36)
Coughing: C21D1(n= 9, 73)	22.22 (16.67)	28.77 (27.95)
Coughing: C22D1(n= 8, 67)	25.00 (38.83)	22.89 (23.36)
Coughing: C23D1(n= 8, 64)	20.83 (17.25)	23.44 (26.35)
Coughing: C24D1(n= 5, 62)	26.67 (14.91)	24.73 (23.33)
Coughing: C25D1(n= 3, 58)	33.33 (0.00)	25.86 (23.40)
Coughing: C26D1(n= 3, 53)	44.44 (19.25)	26.41 (24.77)
Coughing: C27D1(n= 3, 50)	11.11 (19.24)	24.67 (22.14)
Coughing: C28D1(n= 2, 46)	16.67 (23.57)	20.29 (20.46)
Coughing: C29D1(n= 2, 38)	16.67 (23.57)	19.30 (22.77)
Coughing: C30D1(n= 1, 31)	0.00 [1] (NA)	18.28 (20.80)
Coughing: C31D1(n= 0, 24)	NA [2] (NA)	23.61 (25.02)
Coughing: C32D1(n= 0, 23)	NA [2] (NA)	26.09 (19.99)
Coughing: C33D1(n= 0,16)	NA [2] (NA)	27.08 (32.70)
Coughing: C34D1(n= 0, 14)	NA [2] (NA)	26.19 (29.75)
Coughing: C35D1(n= 0, 11)	NA [2] (NA)	21.21 (22.47)
Coughing: C36D1(n= 0, 8)	NA [2] (NA)	25.00 (15.43)
Coughing: C37D1(n= 0, 5)	NA [2] (NA)	26.67 (14.91)
Coughing: C38D1(n= 0, 2)	NA [2] (NA)	33.33 (0.00)
Coughing: EOT(n= 262, 246)	35.75 (27.03)	38.48 (26.95)
Coughing: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	33.33 [1] (NA)
Coughing: Survival FU 1 (n= 2, 1)	50.00 (23.57)	33.33 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

27. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Dysphagia: Baseline (n= 387, 406)	6.20 (17.52)	5.09 (15.05)
Dysphagia: C2D1(n= 336, 358)	10.22 (21.50)	6.42 (15.75)
Dysphagia: C3D1(n= 251, 301)	9.16 (20.87)	5.43 (14.53)
Dysphagia: C4D1(n= 217, 272)	8.60 (19.45)	5.88 (16.39)
Dysphagia: C5D1(n= 163, 236)	6.75 (16.63)	6.64 (16.79)
Dysphagia: C6D1(n= 147, 219)	6.80 (15.58)	4.72 (13.28)
Dysphagia: C7D1(n= 87, 187)	4.21 (11.14)	5.70 (15.17)
Dysphagia: C8D1(n=70, 167)	5.71 (12.65)	4.79 (12.82)
Dysphagia: C9D1(n= 50, 151)	1.33 (6.60)	4.64 (14.42)
Dysphagia: C10D1(n= 47, 143)	1.42 (6.80)	5.36 (15.14)
Dysphagia: C11D1(n= 37, 130)	1.80 (7.64)	2.82 (11.01)
Dysphagia: C12D1(n= 29, 129)	2.30 (8.60)	3.88 (12.93)
Dysphagia: C13D1(n= 19, 121)	0.00 (0.00)	3.86 (11.54)
Dysphagia: C14D1(n= 18, 119)	5.56 (12.78)	5.04 (13.47)
Dysphagia: C15D1(n= 16, 110)	0.00 (0.00)	3.33 (11.01)
Dysphagia: C16D1(n= 13, 106)	0.00 (0.00)	3.77 (12.45)
Dysphagia: C17D1(n= 11, 95)	3.03 (10.05)	3.86 (13.63)
Dysphagia: C18D1(n= 10, 90)	0.00 (0.00)	4.44 (15.96)
Dysphagia: C19D1(n= 9, 82)	3.70 (11.11)	5.28 (15.24)
Dysphagia: C20D1(n= 9, 78)	0.00 (0.00)	4.70 (12.85)
Dysphagia: C21D1(n= 9, 73)	0.00 (0.00)	5.02 (15.39)
Dysphagia: C22D1(n= 8, 67)	0.00 (0.00)	2.99 (11.21)
Dysphagia: C23D1(n= 8, 64)	0.00 (0.00)	3.65 (12.05)
Dysphagia: C24D1(n= 5, 62)	0.00 (0.00)	4.84 (15.79)
Dysphagia: C25D1(n= 3, 58)	0.00 (0.00)	4.02 (15.39)
Dysphagia: C26D1(n= 3, 53)	0.00 (0.00)	4.40 (13.14)
Dysphagia: C27D1(n= 3, 50)	0.00 (0.00)	2.67 (11.35)
Dysphagia: C28D1(n= 2, 46)	0.00 (0.00)	4.35 (15.09)
Dysphagia: C29D1(n= 2, 38)	0.00 (0.00)	4.39 (13.80)
Dysphagia: C30D1(n= 1, 31)	0.00 [1] (NA)	5.38 (15.15)
Dysphagia: C31D1(n= 0, 24)	NA [2] (NA)	5.56 (21.23)
Dysphagia: C32D1(n= 0, 23)	NA [2] (NA)	7.25 (17.28)
Dysphagia: C33D1(n= 0,16)	NA [2] (NA)	6.25 (13.44)
Dysphagia: C34D1(n= 0, 14)	NA [2] (NA)	9.52 (20.38)
Dysphagia: C35D1(n= 0, 11)	NA [2] (NA)	3.03 (10.05)
Dysphagia: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Dysphagia: C37D1(n= 0, 5)	NA [2] (NA)	6.67 (14.91)
Dysphagia: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Dysphagia: EOT(n= 264, 245)	10.23 (20.77)	8.98 (18.87)
Dysphagia: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	0.00 [1] (NA)
Dysphagia: Survival FU 1 (n= 2, 1)	0.00 (0.00)	0.00 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

28. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Dyspnea: Baseline (n= 386, 407)	28.55 (23.21)	26.78 (22.43)
Dyspnea: C2D1(n= 335, 361)	28.14 (23.48)	28.79 (23.67)
Dyspnea: C3D1(n= 252, 301)	28.13 (22.45)	25.40 (20.60)
Dyspnea: C4D1(n= 220, 273)	27.75 (19.85)	25.17 (21.14)
Dyspnea: C5D1(n= 165, 236)	26.57 (19.61)	24.72 (19.90)
Dyspnea: C6D1(n= 148, 221)	29.69 (21.94)	24.01 (21.09)
Dyspnea: C7D1(n= 87, 187)	25.35 (21.07)	24.42 (21.23)
Dyspnea: C8D1(n=70, 167)	28.02 (24.12)	24.42 (22.33)
Dyspnea: C9D1(n= 50, 151)	26.00 (21.49)	22.44 (21.87)
Dyspnea: C10D1(n= 47, 143)	27.42 (22.56)	22.18 (21.35)
Dyspnea: C11D1(n= 37, 130)	22.67 (19.79)	20.43 (21.44)
Dyspnea: C12D1(n= 30, 129)	22.41 (18.94)	22.27 (20.47)
Dyspnea: C13D1(n= 19, 121)	16.37 (15.87)	22.22 (21.52)
Dyspnea: C14D1(n= 18, 119)	17.90 (12.13)	22.41 (20.66)
Dyspnea: C15D1(n= 16, 110)	15.28 (12.75)	22.12 (18.71)
Dyspnea: C16D1(n= 13, 106)	14.53 (13.13)	21.91 (20.71)
Dyspnea: C17D1(n= 10, 95)	18.89 (14.86)	23.51 (21.84)
Dyspnea: C18D1(n= 10, 90)	20.00 (12.61)	22.65 (21.97)
Dyspnea: C19D1(n= 9, 82)	18.52 (13.61)	22.09 (20.91)
Dyspnea: C20D1(n= 9, 78)	20.37 (15.21)	22.65 (21.37)
Dyspnea: C21D1(n= 9, 73)	19.75 (15.49)	20.40 (19.69)
Dyspnea: C22D1(n= 8, 67)	18.06 (20.52)	19.90 (17.68)
Dyspnea: C23D1(n= 8, 64)	16.67 (13.28)	21.2 (19.13)
Dyspnea: C24D1(n= 5, 62)	20.00 (14.49)	21.33 (20.94)
Dyspnea: C25D1(n= 3, 58)	29.63 (25.66)	19.73 (18.39)
Dyspnea: C26D1(n= 3, 53)	22.22 (11.11)	21.80 (19.97)
Dyspnea: C27D1(n= 3, 50)	18.52 (6.41)	20.33 (20.87)
Dyspnea: C28D1(n= 2, 46)	5.56 (7.86)	18.36 (17.87)
Dyspnea: C29D1(n= 2, 38)	5.56 (7.86)	19.30 (16.48)
Dyspnea: C30D1(n= 1, 31)	11.11 [1] (NA)	17.92 (17.14)
Dyspnea: C31D1(n= 0, 24)	NA [2] (NA)	24.07 (18.73)
Dyspnea: C32D1(n= 0, 23)	NA [2] (NA)	24.15 (20.00)
Dyspnea: C33D1(n= 0,16)	NA [2] (NA)	25.69 (27.13)
Dyspnea: C34D1(n= 0, 14)	NA [2] (NA)	27.78 (22.96)
Dyspnea: C35D1(n= 0, 11)	NA [2] (NA)	26.26 (19.42)
Dyspnea: C36D1(n= 0, 8)	NA [2] (NA)	18.06 (13.20)
Dyspnea: C37D1(n= 0, 5)	NA [2] (NA)	24.44 (4.97)
Dyspnea: C38D1(n= 0, 2)	NA [2] (NA)	16.67 (7.86)
Dyspnea: EOT(n= 263, 246)	36.12 (24.82)	34.51 (26.36)
Dyspnea: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	22.22 [1] (NA)
Dyspnea: Survival FU 1 (n= 2, 1)	66.67 (15.71)	44.44 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

29. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Hemoptysis: Baseline (n= 386, 406)	4.32 (13.32)	3.86 (12.12)
Hemoptysis: C2D1(n= 336, 359)	4.76 (14.24)	3.16 (10.97)
Hemoptysis: C3D1(n= 251, 301)	4.38 (13.11)	3.10 (11.12)
Hemoptysis: C4D1(n= 220, 270)	2.88 (10.89)	2.10 (9.94)
Hemoptysis: C5D1(n= 163, 234)	1.43 (7.72)	1.42 (6.76)
Hemoptysis: C6D1(n= 148, 219)	1.80 (7.56)	1.22 (6.27)
Hemoptysis: C7D1(n= 87, 187)	1.15 (6.12)	1.43 (6.76)
Hemoptysis: C8D1(n=70, 166)	1.90 (9.64)	2.41 (10.09)
Hemoptysis: C9D1(n= 50, 151)	2.00 (8.00)	1.77 (7.49)
Hemoptysis: C10D1(n= 47, 143)	2.84 (9.40)	0.70 (4.79)
Hemoptysis: C11D1(n= 37, 130)	1.80 (7.64)	1.03 (5.78)
Hemoptysis: C12D1(n= 30, 129)	0.00 (0.00)	1.03 (5.80)
Hemoptysis: C13D1(n= 19, 121)	3.51 (10.51)	1.10 (5.98)
Hemoptysis: C14D1(n= 18, 119)	1.85 (7.86)	1.68 (7.32)
Hemoptysis: C15D1(n= 16, 110)	0.00 (0.00)	1.82 (10.91)
Hemoptysis: C16D1(n= 13, 106)	0.00 (0.00)	2.83 (10.41)
Hemoptysis: C17D1(n= 11, 94)	0.00 (0.00)	2.84 (12.61)
Hemoptysis: C18D1(n= 10, 90)	0.00 (0.00)	2.96 (12.88)
Hemoptysis: C19D1(n= 9, 82)	0.00 (0.00)	2.03 (12.11)
Hemoptysis: C20D1(n= 9, 78)	0.00 (0.00)	2.56 (12.90)
Hemoptysis: C21D1(n= 8, 73)	0.00 (0.00)	1.83 (7.64)
Hemoptysis: C22D1(n= 8, 67)	0.00 (0.00)	1.99 (9.85)
Hemoptysis: C23D1(n= 8, 64)	0.00 (0.00)	1.04 (5.85)
Hemoptysis: C24D1(n= 5, 61)	0.00 (0.00)	2.73 (11.05)
Hemoptysis: C25D1(n= 3, 58)	0.00 (0.00)	3.45 (13.52)
Hemoptysis: C26D1(n= 3, 53)	0.00 (0.00)	3.77 (14.11)
Hemoptysis: C27D1(n= 3, 50)	0.00 (0.00)	2.00 (8.00)
Hemoptysis: C28D1(n= 2, 46)	33.33 (47.14)	1.45 (6.87)
Hemoptysis: C29D1(n= 2, 38)	0.00 (0.00)	0.88 (5.41)
Hemoptysis: C30D1(n= 1, 31)	0.00 [1] (NA)	1.08 (5.99)
Hemoptysis: C31D1(n= 0, 24)	NA [2] (NA)	2.78 (9.41)
Hemoptysis: C32D1(n= 0, 23)	NA [2] (NA)	2.90 (9.60)
Hemoptysis: C33D1(n= 0,16)	NA [2] (NA)	0.00 (0.00)
Hemoptysis: C34D1(n= 0, 14)	NA [2] (NA)	0.00 (0.00)
Hemoptysis: C35D1(n= 0, 11)	NA [2] (NA)	0.00 (0.00)
Hemoptysis: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Hemoptysis: C37D1(n= 0, 5)	NA [2] (NA)	0.00 (0.00)
Hemoptysis: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Hemoptysis: EOT(n= 264, 243)	5.18 (14.33)	6.04 (16.60)
Hemoptysis: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	0.00 [1] (NA)
Hemoptysis: Survival FU 1 (n= 2, 1)	33.33 (47.14)	0.00 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

30. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Pain in Arm or Shoulder: Baseline (n= 384, 405)	20.49 (28.85)	20.16 (27.09)
Pain in Arm or Shoulder: C2D1(n= 332, 358)	19.58 (27.45)	18.34 (26.56)
Pain in Arm or Shoulder: C3D1(n= 248, 294)	17.20 (27.16)	16.44 (25.50)
Pain in Arm or Shoulder: C4D1(n= 217, 270)	14.75 (23.74)	18.15 (26.57)
Pain in Arm or Shoulder: C5D1(n= 164, 232)	16.06 (24.06)	14.94 (23.76)
Pain in Arm or Shoulder: C6D1(n= 147, 219)	15.42 (23.17)	15.68 (24.37)
Pain in Arm or Shoulder: C7D1(n= 86, 184)	14.73 (23.77)	16.67 (26.31)
Pain in Arm or Shoulder: C8D1(n=69, 163)	15.94 (25.95)	16.77 (25.22)
Pain in Arm or Shoulder: C9D1(n= 50, 149)	14.00 (24.36)	16.78 (25.89)
Pain in Arm or Shoulder: C10D1(n= 46, 141)	14.49 (20.67)	17.73 (27.18)
Pain in Arm or Shoulder: C11D1(n= 36, 127)	11.11 (19.52)	15.49 (26.82)
Pain in Arm or Shoulder: C12D1(n= 30, 126)	12.22 (18.54)	16.93 (26.91)
Pain in Arm or Shoulder: C13D1(n= 19, 117)	12.28 (19.91)	14.81 (22.93)
Pain in Arm or Shoulder: C14D1(n= 18, 117)	11.11 (19.80)	15.67 (22.56)
Pain in Arm or Shoulder: C15D1(n= 16, 108)	12.50 (20.64)	15.74 (24.31)
Pain in Arm or Shoulder: C16D1(n= 13, 104)	7.69 (14.62)	14.10 (23.54)
Pain in Arm or Shoulder: C17D1(n= 11, 93)	9.09 (15.57)	16.49 (25.83)
Pain in Arm or Shoulder: C18D1(n= 10, 88)	13.33 (23.31)	18.18 (25.73)
Pain in Arm or Shoulder: C19D1(n= 9, 80)	7.41 (14.70)	20.83 (29.23)
Pain in Arm or Shoulder: C20D1(n= 9, 76)	11.11 (23.57)	18.42 (25.18)
Pain in Arm or Shoulder: C21D1(n= 9, 71)	11.11 (16.67)	12.68 (19.81)
Pain in Arm or Shoulder: C22D1(n= 8, 65)	16.67 (25.20)	13.33 (21.89)
Pain in Arm or Shoulder: C23D1(n= 8, 62)	16.67 (25.20)	15.05 (22.32)
Pain in Arm or Shoulder: C24D1(n= 5, 59)	20.00 (29.81)	18.08 (24.23)
Pain in Arm or Shoulder: C25D1(n= 3, 57)	11.11 (19.24)	14.62 (21.84)
Pain in Arm or Shoulder: C26D1(n= 2, 52)	16.67 (23.57)	15.38 (22.35)
Pain in Arm or Shoulder: C27D1(n= 3, 49)	11.11 (19.24)	14.97 (23.63)
Pain in Arm or Shoulder: C28D1(n= 2, 45)	0.00 (0.00)	11.85 (19.01)
Pain in Arm or Shoulder: C29D1(n= 2, 37)	0.00 (0.00)	10.81 (22.30)
Pain in Arm or Shoulder: C30D1(n= 1, 30)	0.00 [1] (NA)	10.00 (21.71)
Pain in Arm or Shoulder: C31D1(n= 0, 23)	NA [2] (NA)	10.14 (21.17)
Pain in Arm or Shoulder: C32D1(n= 0, 22)	NA [2] (NA)	13.64 (26.55)
Pain in Arm or Shoulder: C33D1(n= 0, 15)	NA [2] (NA)	20.00 (27.60)
Pain in Arm or Shoulder: C34D1(n= 0, 14)	NA [2] (NA)	16.67 (28.49)
Pain in Arm or Shoulder: C35D1(n= 0, 11)	NA [2] (NA)	27.27 (32.72)
Pain in Arm or Shoulder: C36D1(n= 0, 8)	NA [2] (NA)	16.67 (35.63)
Pain in Arm or Shoulder: C37D1(n= 0, 5)	NA [2] (NA)	33.33 (47.14)
Pain in Arm or Shoulder: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Pain in Arm or Shoulder: EOT(n= 264, 242)	21.72 (30.48)	23.14 (29.55)
Pain in Arm or Shoulder: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	66.67 [1] (NA)
Pain in Arm or Shoulder: Survival FU 1 (n= 2, 1)	83.33 (23.57)	33.33 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

31. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Pain in Chest: Baseline (n= 385, 403)	17.92 (25.33)	19.52 (26.49)
Pain in Chest: C2D1(n= 332, 356)	16.67 (24.65)	15.26 (22.68)
Pain in Chest: C3D1(n= 249, 296)	14.59 (21.92)	15.43 (23.42)
Pain in Chest: C4D1(n= 217, 268)	14.44 (22.37)	14.43 (23.77)
Pain in Chest: C5D1(n= 164, 233)	11.99 (18.42)	12.16 (19.82)
Pain in Chest: C6D1(n= 145, 217)	12.18 (19.96)	12.60 (21.40)
Pain in Chest: C7D1(n= 86, 184)	12.40 (19.83)	11.78 (20.91)
Pain in Chest: C8D1(n=69, 164)	10.63 (20.21)	14.02 (21.52)
Pain in Chest: C9D1(n= 49, 149)	7.48 (17.03)	10.74 (20.96)
Pain in Chest: C10D1(n= 46, 142)	5.07 (12.11)	8.45 (19.62)
Pain in Chest: C11D1(n= 36, 127)	3.70 (10.62)	9.45 (22.18)
Pain in Chest: C12D1(n= 30, 128)	3.33 (10.17)	8.85 (17.49)
Pain in Chest: C13D1(n= 19, 120)	3.51 (10.51)	7.50 (16.99)
Pain in Chest: C14D1(n= 18, 118)	5.56 (12.78)	7.63 (15.96)
Pain in Chest: C15D1(n= 16, 109)	6.25 (13.44)	8.56 (18.37)
Pain in Chest: C16D1(n= 13, 105)	5.13 (12.52)	8.25 (16.53)
Pain in Chest: C17D1(n= 11, 94)	0.00 (0.00)	8.87 (20.84)
Pain in Chest: C18D1(n= 10, 89)	6.67 (14.05)	7.49 (15.69)
Pain in Chest: C19D1(n= 9, 80)	7.41 (14.70)	7.50 (19.10)
Pain in Chest: C20D1(n= 9, 76)	3.70 (11.11)	10.09 (20.38)
Pain in Chest: C21D1(n= 9, 71)	0.00 (0.00)	7.98 (15.39)
Pain in Chest: C22D1(n= 8, 66)	4.17 (11.78)	7.58 (16.33)
Pain in Chest: C23D1(n= 8, 62)	4.17 (11.78)	7.53 (17.51)
Pain in Chest: C24D1(n= 5, 61)	0.00 (0.00)	8.20 (15.70)
Pain in Chest: C25D1(n= 3, 57)	0.00 (0.00)	8.77 (16.09)
Pain in Chest: C26D1(n= 2, 52)	0.00 (0.00)	10.90 (19.49)
Pain in Chest: C27D1(n= 3, 49)	11.11 (19.24)	8.84 (18.97)
Pain in Chest: C28D1(n= 2, 45)	0.00 (0.00)	8.15 (16.14)
Pain in Chest: C29D1(n= 2, 37)	0.00 (0.00)	8.11 (16.49)
Pain in Chest: C30D1(n= 1, 31)	0.00 [1] (NA)	5.38 (12.46)
Pain in Chest: C31D1(n= 0, 24)	NA [2] (NA)	4.17 (11.26)
Pain in Chest: C32D1(n= 0, 23)	NA [2] (NA)	13.04 (19.43)
Pain in Chest: C33D1(n= 0, 16)	NA [2] (NA)	14.58 (24.25)
Pain in Chest: C34D1(n= 0, 14)	NA [2] (NA)	14.29 (25.20)
Pain in Chest: C35D1(n= 0, 11)	NA [2] (NA)	6.06 (13.48)
Pain in Chest: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Pain in Chest: C37D1(n= 0, 5)	NA [2] (NA)	6.67 (14.91)
Pain in Chest: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Pain in Chest: EOT(n= 265, 245)	18.99 (26.35)	19.46 (26.95)
Pain in Chest: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	0.00 [1] (NA)
Pain in Chest: Survival FU 1 (n= 2, 1)	50.00 (70.71)	33.33 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

32. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Peripheral Neuropathy: Baseline (n= 386, 406)	19.26 (28.94)	19.21 (27.77)
Peripheral Neuropathy: C2D1(n= 335, 358)	25.57 (29.63)	20.02 (27.21)
Peripheral Neuropathy: C3D1(n= 250, 300)	25.60 (29.16)	17.78 (25.04)
Peripheral Neuropathy: C4D1(n= 221, 272)	28.05 (29.94)	17.77 (25.75)
Peripheral Neuropathy: C5D1(n= 165, 235)	29.29 (28.94)	18.44 (25.97)
Peripheral Neuropathy: C6D1(n= 147, 221)	31.97 (30.69)	17.50 (25.34)
Peripheral Neuropathy: C7D1(n= 86, 185)	31.01 (30.59)	18.02 (25.29)
Peripheral Neuropathy: C8D1(n=70, 167)	35.24 (26.55)	17.56 (25.30)
Peripheral Neuropathy: C9D1(n= 50, 150)	36.00 (29.23)	15.78 (24.02)
Peripheral Neuropathy: C10D1(n= 47, 143)	36.17 (30.16)	18.18 (25.86)
Peripheral Neuropathy: C11D1(n= 37, 129)	27.93 (24.23)	17.05 (24.69)
Peripheral Neuropathy: C12D1(n= 30, 129)	30.00 (25.30)	17.57 (23.96)
Peripheral Neuropathy: C13D1(n= 19, 121)	26.32 (21.02)	17.91 (25.83)
Peripheral Neuropathy: C14D1(n= 18, 119)	25.93 (21.56)	17.09 (23.72)
Peripheral Neuropathy: C15D1(n= 15, 110)	24.44 (15.26)	17.58 (21.99)
Peripheral Neuropathy: C16D1(n= 13, 105)	20.51 (16.88)	17.14 (24.07)
Peripheral Neuropathy: C17D1(n= 11, 95)	21.21 (16.82)	19.30 (26.44)
Peripheral Neuropathy: C18D1(n= 10, 90)	23.33 (22.50)	18.15 (26.52)
Peripheral Neuropathy: C19D1(n= 9, 82)	14.81 (17.57)	20.33 (26.06)
Peripheral Neuropathy: C20D1(n= 9, 78)	22.22 (23.57)	17.52 (26.17)
Peripheral Neuropathy: C21D1(n= 9, 73)	29.63 (20.03)	18.72 (25.45)
Peripheral Neuropathy: C22D1(n= 7, 66)	23.81 (16.26)	15.66 (23.55)
Peripheral Neuropathy: C23D1(n= 8, 64)	16.67 (17.82)	20.31 (22.71)
Peripheral Neuropathy: C24D1(n= 5, 62)	13.33 (18.26)	20.43 (22.87)
Peripheral Neuropathy: C25D1(n= 3, 58)	11.11 (19.24)	18.39 (20.87)
Peripheral Neuropathy: C26D1(n= 2, 53)	16.67 (23.57)	20.13 (25.60)
Peripheral Neuropathy: C27D1(n= 3, 50)	11.11 (19.24)	19.33 (24.36)
Peripheral Neuropathy: C28D1(n= 2, 46)	0.00 (0.00)	19.57 (22.85)
Peripheral Neuropathy: C29D1(n= 2, 38)	0.00 (0.00)	19.30 (22.77)
Peripheral Neuropathy: C30D1(n= 1, 31)	0.00 [1] (NA)	20.43 (28.12)
Peripheral Neuropathy: C31D1(n= 0, 24)	NA [2] (NA)	23.61 (26.88)
Peripheral Neuropathy: C32D1(n= 0, 23)	NA [2] (NA)	18.84 (22.08)
Peripheral Neuropathy: C33D1(n= 0, 16)	NA [2] (NA)	22.92 (20.07)
Peripheral Neuropathy: C34D1(n= 0, 14)	NA [2] (NA)	19.05 (21.54)
Peripheral Neuropathy: C35D1(n= 0, 11)	NA [2] (NA)	15.15 (17.41)
Peripheral Neuropathy: C36D1(n= 0, 8)	NA [2] (NA)	8.33 (15.43)
Peripheral Neuropathy: C37D1(n= 0, 5)	NA [2] (NA)	26.67 (27.89)
Peripheral Neuropathy: C38D1(n= 0, 2)	NA [2] (NA)	16.67 (23.57)
Peripheral Neuropathy: EOT(n= 262, 244)	31.81 (31.53)	19.54 (27.32)
Peripheral Neuropathy: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	66.67 [1] (NA)
Peripheral Neuropathy: Survival FU 1 (n= 2, 1)	50.00 (23.57)	33.33 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

33. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Pain in Other Parts: Baseline (n= 373, 402)	27.52 (30.41)	27.94 (31.52)
Pain in Other Parts: C2D1(n= 320, 347)	29.58 (30.44)	27.76 (30.53)
Pain in Other Parts: C3D1(n= 239, 286)	22.87 (27.79)	25.87 (29.79)
Pain in Other Parts: C4D1(n= 211, 263)	21.48 (26.86)	23.45 (26.92)
Pain in Other Parts: C5D1(n= 154, 230)	21.21 (26.63)	22.32 (27.24)
Pain in Other Parts: C6D1(n= 139, 214)	22.78 (25.39)	21.50 (27.88)
Pain in Other Parts: C7D1(n= 81, 180)	23.05 (28.21)	24.63 (29.56)
Pain in Other Parts: C8D1(n=65, 158)	24.10 (28.57)	18.35 (24.54)
Pain in Other Parts: C9D1(n= 44, 135)	18.18 (28.26)	21.48 (28.35)
Pain in Other Parts: C10D1(n= 44, 136)	15.15 (23.24)	21.57 (28.84)
Pain in Other Parts: C11D1(n= 34, 123)	14.71 (23.49)	20.05 (27.90)
Pain in Other Parts: C12D1(n= 26, 122)	8.97 (17.78)	16.67 (25.80)
Pain in Other Parts: C13D1(n= 17, 113)	17.65 (23.91)	19.76 (25.05)
Pain in Other Parts: C14D1(n= 18, 115)	18.52 (23.49)	22.03 (29.58)
Pain in Other Parts: C15D1(n= 15, 106)	6.67 (13.80)	19.18 (25.18)
Pain in Other Parts: C16D1(n= 13, 105)	20.51 (21.68)	21.90 (26.89)
Pain in Other Parts: C17D1(n= 11, 93)	15.15 (22.92)	22.22 (27.51)
Pain in Other Parts: C18D1(n= 10, 89)	13.33 (23.31)	22.10 (27.50)
Pain in Other Parts: C19D1(n= 9, 80)	18.52 (24.22)	24.58 (29.88)
Pain in Other Parts: C20D1(n= 9, 74)	25.93 (36.43)	21.17 (27.90)
Pain in Other Parts: C21D1(n= 8, 69)	12.50 (17.25)	21.26 (31.30)
Pain in Other Parts: C22D1(n= 8, 62)	20.83 (24.80)	18.82 (25.34)
Pain in Other Parts: C23D1(n= 8, 62)	20.83 (30.54)	18.82 (23.86)
Pain in Other Parts: C24D1(n= 5, 61)	26.67 (43.46)	19.67 (28.14)
Pain in Other Parts: C25D1(n= 3, 55)	11.11 (19.24)	16.97 (26.35)
Pain in Other Parts: C26D1(n= 2, 50)	16.67 (23.57)	18.67 (26.22)
Pain in Other Parts: C27D1(n= 3, 49)	11.11 (19.24)	14.29 (21.52)
Pain in Other Parts: C28D1(n= 2, 44)	0.00 (0.00)	15.15 (25.37)
Pain in Other Parts: C29D1(n= 2, 36)	0.00 (0.00)	21.30 (26.61)
Pain in Other Parts: C30D1(n= 1, 30)	0.00 [1] (NA)	16.67 (30.01)
Pain in Other Parts: C31D1(n= 0, 23)	NA [2] (NA)	11.59 (21.58)
Pain in Other Parts: C32D1(n= 0, 23)	NA [2] (NA)	20.29 (27.96)
Pain in Other Parts: C33D1(n= 0, 15)	NA [2] (NA)	11.11 (27.22)
Pain in Other Parts: C34D1(n= 0, 14)	NA [2] (NA)	30.95 (33.24)
Pain in Other Parts: C35D1(n= 0, 10)	NA [2] (NA)	26.67 (34.43)
Pain in Other Parts: C36D1(n= 0, 8)	NA [2] (NA)	20.83 (35.36)
Pain in Other Parts: C37D1(n= 0, 5)	NA [2] (NA)	33.33 (40.82)
Pain in Other Parts: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Pain in Other Parts: EOT(n= 250, 226)	30.80 (32.97)	32.01 (33.89)
Pain in Other Parts: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	0.00 [1] (NA)
Pain in Other Parts: Survival FU 1 (n= 2, 1)	83.33 (23.57)	66.67 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

34. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	425	425
Mean (Standard Deviation); Unit of Measure: Units on a scale
Sore Mouth: Baseline (n= 387, 404)	5.68 (16.34)	4.95 (15.32)
Sore Mouth: C2D1(n= 335, 357)	15.52 (25.75)	7.10 (18.17)
Sore Mouth: C3D1(n= 252, 297)	14.29 (23.59)	5.61 (14.18)
Sore Mouth: C4D1(n= 219, 270)	14.00 (22.95)	4.81 (13.99)
Sore Mouth: C5D1(n= 165, 234)	11.31 (19.65)	4.27 (13.49)
Sore Mouth: C6D1(n= 148, 218)	13.29 (23.24)	4.13 (13.89)
Sore Mouth: C7D1(n= 87, 185)	9.20 (20.77)	5.59 (15.50)
Sore Mouth: C8D1(n=70, 166)	8.57 (16.73)	5.02 (14.96)
Sore Mouth: C9D1(n= 50, 151)	6.00 (17.42)	3.09 (14.06)
Sore Mouth: C10D1(n= 47, 143)	7.09 (15.44)	3.96 (14.53)
Sore Mouth: C11D1(n= 37, 130)	4.50 (13.97)	3.33 (12.35)
Sore Mouth: C12D1(n= 30, 129)	2.22 (8.46)	4.65 (14.87)
Sore Mouth: C13D1(n= 19, 121)	1.75 (7.65)	5.23 (15.52)
Sore Mouth: C14D1(n= 18, 119)	3.70 (10.78)	5.32 (15.64)
Sore Mouth: C15D1(n= 15, 110)	0.00 (0.00)	4.24 (13.63)
Sore Mouth: C16D1(n= 13, 106)	0.00 (0.00)	3.77 (16.15)
Sore Mouth: C17D1(n= 11, 95)	3.03 (10.05)	6.32 (17.73)
Sore Mouth: C18D1(n= 10, 90)	3.33 (10.54)	3.70 (11.66)
Sore Mouth: C19D1(n= 9, 82)	0.00 (0.00)	4.47 (12.57)
Sore Mouth: C20D1(n= 9, 78)	0.00 (0.00)	5.56 (15.59)
Sore Mouth: C21D1(n= 9, 73)	0.00 (0.00)	7.76 (17.14)
Sore Mouth: C22D1(n= 8, 67)	4.17 (11.78)	6.47 (17.64)
Sore Mouth: C23D1(n= 8, 64)	4.17 (11.78)	6.25 (16.67)
Sore Mouth: C24D1(n= 5, 62)	0.00 (0.00)	5.38 (13.75)
Sore Mouth: C25D1(n= 3, 57)	0.00 (0.00)	3.51 (10.32)
Sore Mouth: C26D1(n= 3, 53)	0.00 (0.00)	6.92 (13.65)
Sore Mouth: C27D1(n= 3, 50)	0.00 (0.00)	4.00 (10.94)
Sore Mouth: C28D1(n= 2, 46)	0.00 (0.00)	4.35 (11.35)
Sore Mouth: C29D1(n= 2, 38)	0.00 (0.00)	3.51 (10.37)
Sore Mouth: C30D1(n= 1, 31)	0.00 [1] (NA)	4.30 (11.36)
Sore Mouth: C31D1(n= 0, 24)	NA [2] (NA)	4.17 (11.26)
Sore Mouth: C32D1(n= 0, 23)	NA [2] (NA)	4.35 (11.48)
Sore Mouth: C33D1(n= 0, 16)	NA [2] (NA)	4.17 (11.39)
Sore Mouth: C34D1(n= 0, 14)	NA [2] (NA)	9.52 (15.63)
Sore Mouth: C35D1(n= 0, 11)	NA [2] (NA)	6.06 (13.48)
Sore Mouth: C36D1(n= 0, 8)	NA [2] (NA)	4.17 (11.78)
Sore Mouth: C37D1(n= 0, 5)	NA [2] (NA)	13.33 (29.81)
Sore Mouth: C38D1(n= 0, 2)	NA [2] (NA)	0.00 (0.00)
Sore Mouth: EOT(n= 265, 243)	11.57 (22.85)	7.00 (17.18)
Sore Mouth: Pro Week 6 Pd(n= 0,1)	NA [2] (NA)	66.67 [1] (NA)
Sore Mouth: Survival FU 1 (n= 2, 1)	16.67 (23.57)	0.00 [1] (NA)

[1]

Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

[2]

Data not reported because no participant was evaluated for this category

35. Secondary Outcome

Title	PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	612	613
Median (95% Confidence Interval); Unit of Measure: Months
	3.8; (3.3 to 4.1)	2.7; (2.4 to 2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4981
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Stratified Hazard Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.08
	Estimation Comments	[Not Specified]

36. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
Description	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	612	613
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	11.8; (9.32 to 14.59)	13.7; (11.08 to 16.68)

37. Secondary Outcome

Title	DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

The SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description:	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed	72	84
Median (95% Confidence Interval); Unit of Measure: Months
	6.3; (5.5 to 7.6)	23.9 [1]; (12.8 to NA)

[1]

Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Unstratified Hazard Ratio
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.48
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Baseline up to approximately 5.28 years.
Adverse Event Reporting Description	Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
All-Cause Mortality
	Docetaxel	Atezolizumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Docetaxel	Atezolizumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	180/578 (31.14%)	200/609 (32.84%)
Blood and lymphatic system disorders
Anaemia * 1	7/578 (1.21%)	5/609 (0.82%)
Febrile neutropenia * 1	37/578 (6.40%)	0/609 (0.00%)
Leukocytosis * 1	1/578 (0.17%)	0/609 (0.00%)
Neutropenia * 1	3/578 (0.52%)	0/609 (0.00%)
Cardiac disorders
Acute myocardial infarction * 1	2/578 (0.35%)	0/609 (0.00%)
Angina pectoris * 1	1/578 (0.17%)	0/609 (0.00%)
Arrhythmia * 1	1/578 (0.17%)	0/609 (0.00%)
Atrial fibrillation * 1	3/578 (0.52%)	1/609 (0.16%)
Atrial flutter * 1	1/578 (0.17%)	0/609 (0.00%)
Cardiac arrest * 1	1/578 (0.17%)	0/609 (0.00%)
Cardiac tamponade * 1	0/578 (0.00%)	2/609 (0.33%)
Left ventricular dysfunction * 1	0/578 (0.00%)	1/609 (0.16%)
Myocardial infarction * 1	0/578 (0.00%)	2/609 (0.33%)
Myocardial ischaemia * 1	0/578 (0.00%)	1/609 (0.16%)
Pericardial effusion * 1	1/578 (0.17%)	3/609 (0.49%)
Pericarditis * 1	0/578 (0.00%)	1/609 (0.16%)
Stress cardiomyopathy * 1	1/578 (0.17%)	0/609 (0.00%)
Supraventricular tachycardia * 1	2/578 (0.35%)	0/609 (0.00%)
Tachycardia * 1	1/578 (0.17%)	1/609 (0.16%)
Tachycardia paroxysmal * 1	0/578 (0.00%)	1/609 (0.16%)
Cardiac failure congestive * 1	0/578 (0.00%)	1/609 (0.16%)
Eye disorders
Retinopathy * 1	0/578 (0.00%)	1/609 (0.16%)
Gastrointestinal disorders
Abdominal pain * 1	4/578 (0.69%)	1/609 (0.16%)
Abdominal pain lower * 1	0/578 (0.00%)	2/609 (0.33%)
Abdominal pain upper * 1	1/578 (0.17%)	1/609 (0.16%)
Colitis * 1	2/578 (0.35%)	2/609 (0.33%)
Constipation * 1	0/578 (0.00%)	1/609 (0.16%)
Diarrhoea * 1	7/578 (1.21%)	1/609 (0.16%)
Duodenal perforation * 1	1/578 (0.17%)	0/609 (0.00%)
Dysphagia * 1	1/578 (0.17%)	1/609 (0.16%)
Faeces discoloured * 1	0/578 (0.00%)	1/609 (0.16%)
Gastritis erosive * 1	0/578 (0.00%)	1/609 (0.16%)
Haematochezia * 1	1/578 (0.17%)	0/609 (0.00%)
Intestinal obstruction * 1	0/578 (0.00%)	1/609 (0.16%)
Lower gastrointestinal haemorrhage * 1	1/578 (0.17%)	0/609 (0.00%)
Melaena * 1	0/578 (0.00%)	1/609 (0.16%)
Nausea * 1	1/578 (0.17%)	2/609 (0.33%)
Oesophageal fistula * 1	1/578 (0.17%)	0/609 (0.00%)
Oesophageal obstruction * 1	0/578 (0.00%)	1/609 (0.16%)
Oesophageal varices haemorrhage * 1	1/578 (0.17%)	0/609 (0.00%)
Pancreatitis * 1	0/578 (0.00%)	1/609 (0.16%)
Stomatitis * 1	1/578 (0.17%)	0/609 (0.00%)
Subileus * 1	1/578 (0.17%)	0/609 (0.00%)
Upper gastrointestinal haemorrhage * 1	1/578 (0.17%)	0/609 (0.00%)
Vomiting * 1	5/578 (0.87%)	1/609 (0.16%)
Small intestinal obstruction * 1	1/578 (0.17%)	1/609 (0.16%)
General disorders
Asthenia * 1	3/578 (0.52%)	3/609 (0.49%)
Chest discomfort * 1	0/578 (0.00%)	1/609 (0.16%)
Chest pain * 1	1/578 (0.17%)	0/609 (0.00%)
Death * 1	0/578 (0.00%)	1/609 (0.16%)
Fatigue * 1	4/578 (0.69%)	2/609 (0.33%)
General physical health deterioration * 1	0/578 (0.00%)	2/609 (0.33%)
Generalised oedema * 1	1/578 (0.17%)	0/609 (0.00%)
Influenza like illness * 1	0/578 (0.00%)	1/609 (0.16%)
Localised oedema * 1	0/578 (0.00%)	1/609 (0.16%)
Oedema peripheral * 1	0/578 (0.00%)	2/609 (0.33%)
Pain * 1	1/578 (0.17%)	0/609 (0.00%)
Pyrexia * 1	8/578 (1.38%)	9/609 (1.48%)
Sudden death * 1	2/578 (0.35%)	1/609 (0.16%)
Systemic inflammatory response syndrome * 1	0/578 (0.00%)	1/609 (0.16%)
Hepatobiliary disorders
Acute hepatic failure * 1	1/578 (0.17%)	0/609 (0.00%)
Cholecystitis * 1	1/578 (0.17%)	0/609 (0.00%)
Cholecystitis acute * 1	1/578 (0.17%)	1/609 (0.16%)
Drug-induced liver injury * 1	0/578 (0.00%)	1/609 (0.16%)
Hepatitis * 1	0/578 (0.00%)	2/609 (0.33%)
Hepatitis acute * 1	0/578 (0.00%)	1/609 (0.16%)
Immune system disorders
Hypersensitivity * 1	0/578 (0.00%)	3/609 (0.49%)
Infections and infestations
Abdominal sepsis * 1	1/578 (0.17%)	0/609 (0.00%)
Appendicitis * 1	1/578 (0.17%)	0/609 (0.00%)
Bacterial sepsis * 1	1/578 (0.17%)	0/609 (0.00%)
Bronchitis * 1	2/578 (0.35%)	1/609 (0.16%)
Cellulitis * 1	2/578 (0.35%)	1/609 (0.16%)
Clostridium difficile colitis * 1	1/578 (0.17%)	0/609 (0.00%)
Clostridium difficile infection * 1	0/578 (0.00%)	1/609 (0.16%)
Device related infection * 1	1/578 (0.17%)	1/609 (0.16%)
Diverticulitis * 1	2/578 (0.35%)	0/609 (0.00%)
Encephalitis * 1	0/578 (0.00%)	1/609 (0.16%)
Enteritis infectious * 1	0/578 (0.00%)	1/609 (0.16%)
Febrile infection * 1	0/578 (0.00%)	1/609 (0.16%)
Gastroenteritis * 1	1/578 (0.17%)	1/609 (0.16%)
Gastrointestinal fungal infection * 1	1/578 (0.17%)	0/609 (0.00%)
Gastrointestinal infection * 1	1/578 (0.17%)	0/609 (0.00%)
Infected skin ulcer * 1	0/578 (0.00%)	1/609 (0.16%)
Infection * 1	2/578 (0.35%)	0/609 (0.00%)
Infectious pleural effusion * 1	0/578 (0.00%)	1/609 (0.16%)
Infective exacerbation of chronic obstructive airways disease * 1	0/578 (0.00%)	1/609 (0.16%)
Influenza * 1	1/578 (0.17%)	2/609 (0.33%)
Lower respiratory tract infection * 1	3/578 (0.52%)	3/609 (0.49%)
Lung infection * 1	3/578 (0.52%)	3/609 (0.49%)
Meningitis * 1	0/578 (0.00%)	3/609 (0.49%)
Neutropenic sepsis * 1	2/578 (0.35%)	0/609 (0.00%)
Paronychia * 1	1/578 (0.17%)	0/609 (0.00%)
Parotitis * 1	0/578 (0.00%)	1/609 (0.16%)
Pharyngitis * 1	0/578 (0.00%)	2/609 (0.33%)
Pleural infection * 1	1/578 (0.17%)	0/609 (0.00%)
Pneumocystis jirovecii pneumonia * 1	0/578 (0.00%)	1/609 (0.16%)
Pneumonia * 1	34/578 (5.88%)	20/609 (3.28%)
Pneumonia bacterial * 1	0/578 (0.00%)	1/609 (0.16%)
Pseudomembranous colitis * 1	0/578 (0.00%)	1/609 (0.16%)
Pulmonary sepsis * 1	0/578 (0.00%)	2/609 (0.33%)
Respiratory tract infection * 1	4/578 (0.69%)	8/609 (1.31%)
Sepsis * 1	2/578 (0.35%)	5/609 (0.82%)
Septic shock * 1	1/578 (0.17%)	1/609 (0.16%)
Skin infection * 1	1/578 (0.17%)	0/609 (0.00%)
Tonsillitis * 1	0/578 (0.00%)	1/609 (0.16%)
Upper respiratory tract infection bacterial * 1	0/578 (0.00%)	1/609 (0.16%)
Urinary tract infection * 1	2/578 (0.35%)	0/609 (0.00%)
Urosepsis * 1	0/578 (0.00%)	1/609 (0.16%)
Gastroenteritis viral * 1	0/578 (0.00%)	1/609 (0.16%)
Localised infection * 1	0/578 (0.00%)	1/609 (0.16%)
Pyelonephritis * 1	0/578 (0.00%)	1/609 (0.16%)
Injury, poisoning and procedural complications
Burns third degree * 1	0/578 (0.00%)	1/609 (0.16%)
Fall * 1	1/578 (0.17%)	1/609 (0.16%)
Hip fracture * 1	0/578 (0.00%)	3/609 (0.49%)
Humerus fracture * 1	1/578 (0.17%)	1/609 (0.16%)
Infusion related reaction * 1	0/578 (0.00%)	1/609 (0.16%)
Lumbar vertebral fracture * 1	0/578 (0.00%)	1/609 (0.16%)
Overdose * 1	1/578 (0.17%)	0/609 (0.00%)
Post procedural haematuria * 1	1/578 (0.17%)	0/609 (0.00%)
Radius fracture * 1	0/578 (0.00%)	1/609 (0.16%)
Spinal compression fracture * 1	0/578 (0.00%)	1/609 (0.16%)
Upper limb fracture * 1	1/578 (0.17%)	0/609 (0.00%)
Ankle fracture * 1	0/578 (0.00%)	1/609 (0.16%)
Femoral neck fracture * 1	0/578 (0.00%)	1/609 (0.16%)
Fracture displacement * 1	1/578 (0.17%)	0/609 (0.00%)
Investigations
Alanine aminotransferase increased * 1	0/578 (0.00%)	1/609 (0.16%)
Aspartate aminotransferase increased * 1	0/578 (0.00%)	1/609 (0.16%)
Neutrophil count decreased * 1	5/578 (0.87%)	0/609 (0.00%)
White blood cell count decreased * 1	1/578 (0.17%)	0/609 (0.00%)
Metabolism and nutrition disorders
Decreased appetite * 1	1/578 (0.17%)	0/609 (0.00%)
Dehydration * 1	3/578 (0.52%)	1/609 (0.16%)
Failure to thrive * 1	0/578 (0.00%)	1/609 (0.16%)
Hypercalcaemia * 1	0/578 (0.00%)	1/609 (0.16%)
Hyperglycaemia * 1	0/578 (0.00%)	3/609 (0.49%)
Hypoglycaemia * 1	1/578 (0.17%)	0/609 (0.00%)
Hypokalaemia * 1	1/578 (0.17%)	0/609 (0.00%)
Hyponatraemia * 1	1/578 (0.17%)	1/609 (0.16%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/578 (0.00%)	2/609 (0.33%)
Back pain * 1	2/578 (0.35%)	3/609 (0.49%)
Bone pain * 1	0/578 (0.00%)	4/609 (0.66%)
Musculoskeletal chest pain * 1	0/578 (0.00%)	2/609 (0.33%)
Musculoskeletal pain * 1	1/578 (0.17%)	1/609 (0.16%)
Myalgia * 1	1/578 (0.17%)	0/609 (0.00%)
Neck pain * 1	0/578 (0.00%)	1/609 (0.16%)
Pain in extremity * 1	0/578 (0.00%)	1/609 (0.16%)
Rhabdomyolysis * 1	0/578 (0.00%)	1/609 (0.16%)
Muscular weakness * 1	0/578 (0.00%)	1/609 (0.16%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain * 1	1/578 (0.17%)	0/609 (0.00%)
Colon cancer * 1	1/578 (0.17%)	0/609 (0.00%)
Neoplasm malignant * 1	0/578 (0.00%)	1/609 (0.16%)
Prostate cancer * 1	0/578 (0.00%)	1/609 (0.16%)
Basal cell carcinoma * 1	0/578 (0.00%)	1/609 (0.16%)
Nervous system disorders
Aphasia * 1	0/578 (0.00%)	1/609 (0.16%)
Cerebral artery embolism * 1	0/578 (0.00%)	1/609 (0.16%)
Cerebral thrombosis * 1	1/578 (0.17%)	0/609 (0.00%)
Cerebrovascular accident * 1	0/578 (0.00%)	2/609 (0.33%)
Cognitive disorder * 1	0/578 (0.00%)	1/609 (0.16%)
Depressed level of consciousness * 1	0/578 (0.00%)	1/609 (0.16%)
Dizziness * 1	1/578 (0.17%)	1/609 (0.16%)
Encephalopathy * 1	0/578 (0.00%)	1/609 (0.16%)
Generalised tonic-clonic seizure * 1	0/578 (0.00%)	1/609 (0.16%)
Guillain-Barre syndrome * 1	0/578 (0.00%)	2/609 (0.33%)
Hemiparesis * 1	0/578 (0.00%)	1/609 (0.16%)
Leukoencephalopathy * 1	0/578 (0.00%)	1/609 (0.16%)
Neuralgia * 1	0/578 (0.00%)	1/609 (0.16%)
Peripheral sensory neuropathy * 1	0/578 (0.00%)	1/609 (0.16%)
Sciatica * 1	1/578 (0.17%)	0/609 (0.00%)
Seizure * 1	1/578 (0.17%)	3/609 (0.49%)
Syncope * 1	3/578 (0.52%)	1/609 (0.16%)
Haemorrhage intracranial * 1	0/578 (0.00%)	1/609 (0.16%)
Psychiatric disorders
Confusional state * 1	2/578 (0.35%)	1/609 (0.16%)
Mental status change * 1	0/578 (0.00%)	1/609 (0.16%)
Renal and urinary disorders
Acute kidney injury * 1	4/578 (0.69%)	1/609 (0.16%)
Haematuria * 1	0/578 (0.00%)	1/609 (0.16%)
Henoch-Schonlein purpura nephritis * 1	0/578 (0.00%)	1/609 (0.16%)
Renal failure * 1	0/578 (0.00%)	1/609 (0.16%)
Reproductive system and breast disorders
Benign prostatic hyperplasia * 1	0/578 (0.00%)	1/609 (0.16%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome * 1	0/578 (0.00%)	1/609 (0.16%)
Acute respiratory failure * 1	0/578 (0.00%)	1/609 (0.16%)
Aspiration * 1	0/578 (0.00%)	1/609 (0.16%)
Atelectasis * 1	0/578 (0.00%)	1/609 (0.16%)
Bronchial obstruction * 1	1/578 (0.17%)	0/609 (0.00%)
Bronchospasm * 1	0/578 (0.00%)	1/609 (0.16%)
Chronic obstructive pulmonary disease * 1	3/578 (0.52%)	2/609 (0.33%)
Cough * 1	0/578 (0.00%)	1/609 (0.16%)
Dyspnoea * 1	7/578 (1.21%)	13/609 (2.13%)
Emphysema * 1	0/578 (0.00%)	1/609 (0.16%)
Haemoptysis * 1	5/578 (0.87%)	6/609 (0.99%)
Hypoxia * 1	1/578 (0.17%)	3/609 (0.49%)
Interstitial lung disease * 1	0/578 (0.00%)	1/609 (0.16%)
Organising pneumonia * 1	0/578 (0.00%)	1/609 (0.16%)
Pleural effusion * 1	5/578 (0.87%)	11/609 (1.81%)
Pleural fistula * 1	0/578 (0.00%)	1/609 (0.16%)
Pleuritic pain * 1	0/578 (0.00%)	1/609 (0.16%)
Pneumonia aspiration * 1	0/578 (0.00%)	2/609 (0.33%)
Pneumonitis * 1	1/578 (0.17%)	6/609 (0.99%)
Pneumothorax * 1	2/578 (0.35%)	3/609 (0.49%)
Pneumothorax spontaneous * 1	1/578 (0.17%)	0/609 (0.00%)
Pulmonary embolism * 1	2/578 (0.35%)	9/609 (1.48%)
Pulmonary haemorrhage * 1	2/578 (0.35%)	1/609 (0.16%)
Pulmonary oedema * 1	1/578 (0.17%)	1/609 (0.16%)
Respiratory distress * 1	1/578 (0.17%)	0/609 (0.00%)
Respiratory failure * 1	2/578 (0.35%)	3/609 (0.49%)
Tachypnoea * 1	0/578 (0.00%)	1/609 (0.16%)
Skin and subcutaneous tissue disorders
Pemphigoid * 1	0/578 (0.00%)	1/609 (0.16%)
Pruritus * 1	0/578 (0.00%)	1/609 (0.16%)
Pruritus generalised * 1	0/578 (0.00%)	1/609 (0.16%)
Vascular disorders
Deep vein thrombosis * 1	2/578 (0.35%)	1/609 (0.16%)
Haematoma * 1	1/578 (0.17%)	0/609 (0.00%)
Hypotension * 1	1/578 (0.17%)	3/609 (0.49%)
Superior vena cava syndrome * 1	1/578 (0.17%)	3/609 (0.49%)
Thrombosis * 1	0/578 (0.00%)	1/609 (0.16%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA v22.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Docetaxel	Atezolizumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	535/578 (92.56%)	541/609 (88.83%)
Blood and lymphatic system disorders
Anaemia * 1	130/578 (22.49%)	71/609 (11.66%)
Neutropenia * 1	88/578 (15.22%)	12/609 (1.97%)
Eye disorders
Lacrimation increased * 1	33/578 (5.71%)	6/609 (0.99%)
Gastrointestinal disorders
Abdominal pain * 1	33/578 (5.71%)	23/609 (3.78%)
Constipation * 1	82/578 (14.19%)	111/609 (18.23%)
Diarrhoea * 1	138/578 (23.88%)	100/609 (16.42%)
Nausea * 1	131/578 (22.66%)	110/609 (18.06%)
Stomatitis * 1	62/578 (10.73%)	21/609 (3.45%)
Vomiting * 1	61/578 (10.55%)	75/609 (12.32%)
General disorders
Asthenia * 1	113/578 (19.55%)	117/609 (19.21%)
Chest pain * 1	25/578 (4.33%)	55/609 (9.03%)
Fatigue * 1	206/578 (35.64%)	165/609 (27.09%)
Influenza like illness * 1	14/578 (2.42%)	35/609 (5.75%)
Malaise * 1	29/578 (5.02%)	15/609 (2.46%)
Mucosal inflammation * 1	41/578 (7.09%)	9/609 (1.48%)
Oedema peripheral * 1	82/578 (14.19%)	55/609 (9.03%)
Pyrexia * 1	70/578 (12.11%)	108/609 (17.73%)
Infections and infestations
Nasopharyngitis * 1	21/578 (3.63%)	39/609 (6.40%)
Upper respiratory tract infection * 1	15/578 (2.60%)	41/609 (6.73%)
Urinary tract infection * 1	30/578 (5.19%)	22/609 (3.61%)
Bronchitis * 1	24/578 (4.15%)	34/609 (5.58%)
Investigations
Alanine aminotransferase increased * 1	14/578 (2.42%)	36/609 (5.91%)
Aspartate aminotransferase increased * 1	12/578 (2.08%)	42/609 (6.90%)
Neutrophil count decreased * 1	50/578 (8.65%)	3/609 (0.49%)
Weight decreased * 1	30/578 (5.19%)	56/609 (9.20%)
Metabolism and nutrition disorders
Decreased appetite * 1	135/578 (23.36%)	150/609 (24.63%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	59/578 (10.21%)	80/609 (13.14%)
Back pain * 1	41/578 (7.09%)	70/609 (11.49%)
Musculoskeletal pain * 1	24/578 (4.15%)	69/609 (11.33%)
Myalgia * 1	90/578 (15.57%)	44/609 (7.22%)
Pain in extremity * 1	38/578 (6.57%)	56/609 (9.20%)
Musculoskeletal chest pain * 1	7/578 (1.21%)	33/609 (5.42%)
Nervous system disorders
Dizziness * 1	32/578 (5.54%)	48/609 (7.88%)
Dysgeusia * 1	48/578 (8.30%)	18/609 (2.96%)
Headache * 1	46/578 (7.96%)	62/609 (10.18%)
Neuropathy peripheral * 1	65/578 (11.25%)	27/609 (4.43%)
Paraesthesia * 1	45/578 (7.79%)	23/609 (3.78%)
Peripheral sensory neuropathy * 1	43/578 (7.44%)	5/609 (0.82%)
Psychiatric disorders
Depression * 1	6/578 (1.04%)	31/609 (5.09%)
Insomnia * 1	43/578 (7.44%)	56/609 (9.20%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	107/578 (18.51%)	146/609 (23.97%)
Dyspnoea * 1	108/578 (18.69%)	117/609 (19.21%)
Haemoptysis * 1	28/578 (4.84%)	40/609 (6.57%)
Productive cough * 1	21/578 (3.63%)	36/609 (5.91%)
Skin and subcutaneous tissue disorders
Alopecia * 1	205/578 (35.47%)	5/609 (0.82%)
Dry skin * 1	34/578 (5.88%)	30/609 (4.93%)
Nail disorder * 1	30/578 (5.19%)	1/609 (0.16%)
Pruritus * 1	18/578 (3.11%)	57/609 (9.36%)
Rash * 1	51/578 (8.82%)	65/609 (10.67%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA v22.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

• Name/Title: Medical Communications
• Organization: Hoffmann-La Roche
• Phone: 800-821-8590
• EMail: genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21.

Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30.

Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882.

Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.

Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.

Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.

Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum In: Lancet. 2017 Apr 8;389(10077):e5.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02008227
• Other Study ID Numbers: GO28915; 2013-003331-30 ( EudraCT Number )
• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Results First Submitted: May 8, 2017
• Results First Posted: July 2, 2017
• Last Update Posted: December 20, 2019