A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

• ClinicalTrials.gov Identifier: NCT02409342
• Recruitment Status: Completed
• First Posted: April 6, 2015
• Results First Posted: February 18, 2021
• Last Update Posted: March 15, 2023
• 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, Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed
• Enrollment: 572

Participant Flow

Recruitment Details

Recruitment included: Japan (16 centers), Spain (15 centers), Greece (12 centers), Italy (12 centers), Brazil (11 centers), Russian (11 centers), France (10 centers), United States of America (9 centers), Ukraine (8 centers), Romania (7 centers), Turkey (6 centers), Poland (5 centers), Serbia (5 centers), Hungary (4 centers), Thailand (4 centers), Great Britain (3 centers), Republic of Korea (3 centers), Germany (2 centers), China (1 center).

Pre-assignment Details

Study is considered 'Completed' because all of the criteria for End of Study have been met. Participants in survival follow-up completed their last visit and participants on active treatment were rolled over to a rollover study to continue their treatment.

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Period Title: Overall Study
Started	287	285
Completed	0	0
Not Completed	287	285
Reason Not Completed
Death	211	201
Withdrawal by Subject	24	17
Study Terminated By Sponsor	48	59
Lost to Follow-up	3	5
Local ethics requires subjects' data be removed from aug 2020 to currently.	0	1
Participant Moved Into Roll-Over Study	0	2
Sponsor Decision	1	0

Baseline Characteristics

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab	Total
Arm/Group Description		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).	Total of all reporting groups
Overall Number of Baseline Participants		287	285	572
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	287 participants	285 participants	572 participants
		63.8 (8.8)	63.1 (8.8)	63.4 (8.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	287 participants	285 participants	572 participants
	Female	89 31.0%	87 30.5%	176 30.8%
	Male	198 69.0%	198 69.5%	396 69.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	287 participants	285 participants	572 participants
	Hispanic or Latino	14 4.9%	21 7.4%	35 6.1%
	Not Hispanic or Latino	265 92.3%	262 91.9%	527 92.1%
	Unknown or Not Reported	8 2.8%	2 0.7%	10 1.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	287 participants	285 participants	572 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	33 11.5%	48 16.8%	81 14.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 0.7%	2 0.7%	4 0.7%
	White	247 86.1%	232 81.4%	479 83.7%
	More than one race	0 0.0%	1 0.4%	1 0.2%
	Unknown or Not Reported	5 1.7%	2 0.7%	7 1.2%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) in the TC3 or IC3-WT Populations
Description	OS is defined as the time from randomization to death from any cause.
Time Frame	From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Median (95% Confidence Interval); Unit of Measure: Months
	13.1; (7.4 to 16.5)	20.2 [1]; (16.5 to NA)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.
Statistical Test of Hypothesis	P-Value	0.0106
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.595
	Confidence Interval	(2-Sided) 95%; 0.398 to 0.890
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	OS is defined as the time from randomization to death from any cause.
Time Frame	From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		277	277
Median (95% Confidence Interval); Unit of Measure: Months
TC2/3 or IC2/3-WT Population	Number Analyzed	162 participants	166 participants
		16.1; (12.6 to 18.0)	19.9; (17.2 to 25.3)
TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	277 participants	277 participants
		14.7; (11.2 to 16.5)	18.9; (13.4 to 23.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.
Statistical Test of Hypothesis	P-Value	0.3091
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.868
	Confidence Interval	(2-Sided) 95%; 0.661 to 1.140
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC1/2/3 or IC/1/2/3-WT
	Type of Statistical Test	Superiority
	Comments	Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.
Statistical Test of Hypothesis	P-Value	0.1070
	Comments	P-value is descriptive as it was not formally tested.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.845
	Confidence Interval	(2-Sided) 95%; 0.688 to 1.037
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
Description	PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Time Frame	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Months
	5.0; (4.2 to 5.7)	8.1; (6.8 to 11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Statistical Test of Hypothesis	P-Value	0.0070
	Comments	P-value is descriptive as it was not formally tested.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.630
	Confidence Interval	(2-Sided) 95%; 0.449 to 0.884
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Time Frame	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		277	277
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Months
TC2/3 or IC2/3-WT Population	Number Analyzed	162 participants	166 participants
		5.5; (4.5 to 5.7)	7.3; (5.6 to 9.3)
TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	277 participants	277 participants
		5.6; (4.7 to 5.7)	5.8; (5.5 to 7.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
	Comments	TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	P-value is descriptive as it was not formally tested.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.641
	Confidence Interval	(2-Sided) 95%; 0.501 to 0.820
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC1/2/3 or IC1/2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	P-value is descriptive as it was not formally tested.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.716
	Confidence Interval	(2-Sided) 95%; 0.595 to 0.863
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
Description	Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Time Frame	Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Measure Type: Number; Unit of Measure: Percentage of participants
	28.6	38.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Method of Estimation	Estimation Parameter	Difference in ORR
	Estimated Value	9.75
	Confidence Interval	(2-Sided) 95%; -4.07 to 23.56
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Time Frame	Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		277	277
Measure Type: Number; Unit of Measure: Percentage of participants
TC2/3 or IC2/3-WT Population	Number Analyzed	162 participants	166 participants
		32.1	33.7
TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	277 participants	277 participants
		32.1	31.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Difference in ORR
	Estimated Value	1.64
	Confidence Interval	(2-Sided) 95%; -9.14 to 12.42
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC1/2/3 or IC1/2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Difference in ORR
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -8.84 to 7.39
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Duration of Response (DOR) in the TC3 or IC3-WT Populations
Description	DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame	From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	28	41
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Months
	6.7; (5.5 to 17.3)	NA [1]; (11.8 to NA)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.365
	Confidence Interval	(2-Sided) 95%; 0.166 to 0.800
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame	From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		89	87
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Months
TC2/3 or IC2/3-WT Population	Number Analyzed	52 participants	56 participants
		5.8; (5.1 to 9.8)	38.9 [1]; (16.9 to NA)
TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	89 participants	87 participants
		5.7; (5.1 to 8.8)	26.3; (16.1 to 43.7)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.235
	Confidence Interval	(2-Sided) 95%; 0.135 to 0.409
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	TC1/2/3 or IC1/2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.284
	Confidence Interval	(2-Sided) 95%; 0.190 to 0.424
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations
Description	[Not Specified]
Time Frame	Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	50.64; (40.00 to 61.27)	64.90; (55.36 to 74.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	1-Year TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	14.26
	Confidence Interval	(2-Sided) 95%; -0.03 to 28.55
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
Description	[Not Specified]
Time Frame	Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	24.79; (13.11 to 36.47)	45.49; (32.11 to 58.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	2-Years TC3 or IC3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	20.70
	Confidence Interval	(2-Sided) 95%; 2.94 to 38.47
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	[Not Specified]
Time Frame	Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		277	277
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
1-Year TC2/3 or IC2/3-WT Population	Number Analyzed	162 participants	166 participants
		58.65; (50.95 to 66.35)	63.39; (56.00 to 70.77)
1-Year TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	277 participants	277 participants
		54.89; (48.93 to 60.84)	59.95; (54.12 to 65.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	1-Year TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	4.74
	Confidence Interval	(2-Sided) 95%; -5.93 to 15.40
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	1-Year TC1/2/3 or IC1/2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	5.06
	Confidence Interval	(2-Sided) 95%; -3.27 to 13.40
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description	[Not Specified]
Time Frame	Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]).

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		277	277
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
2-Years TC2/3 or IC2/3-WT Population	Number Analyzed	162 participants	166 participants
		35.42; (27.91 to 42.94)	44.15; (36.51 to 51.80)
2-Years TC1/2/3 or IC1/2/3-WT Population	Number Analyzed	277 participants	277 participants
		30.82; (25.28 to 36.36)	41.76; (35.84 to 47.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	2-Years TC2/3 or IC2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	8.73
	Confidence Interval	(2-Sided) 95%; -1.99 to 19.45
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	2-Years TC1/2/3 or IC1/2/3-WT Population
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Event Free Rate
	Estimated Value	10.94
	Confidence Interval	(2-Sided) 95%; 2.83 to 19.04
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Description	TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Time Frame	Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT Populations.

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Median (95% Confidence Interval); Unit of Measure: Months
Cough	3.4; (1.3 to 12.4)	3.5; (1.0 to 10.8)
Dyspnea	1.0; (0.5 to 1.9)	1.3; (0.7 to 3.6)
Chest pain	1.1 [1]; (0.7 to NA)	1.7; (0.7 to 4.5)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Cough in TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified Analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.142
	Confidence Interval	(2-Sided) 95%; 0.657 to 1.984
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Dyspnoea in TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.891
	Confidence Interval	(2-Sided) 95%; 0.555 to 1.430
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Chest pain in TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.229
	Confidence Interval	(2-Sided) 95%; 0.737 to 2.049
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Description	Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Time Frame	Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT Populations.

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		52	61
Mean (Standard Deviation); Unit of Measure: Score on a scale
Chest Pain, Week 1	Number Analyzed	44 participants	47 participants
		0.57 (1.23)	0.31 (0.84)
Chest Pain, Week 2	Number Analyzed	42 participants	48 participants
		0.42 (1.13)	0.33 (0.85)
Chest Pain, Week 3	Number Analyzed	44 participants	49 participants
		0.25 (1.26)	0.43 (0.97)
Chest Pain, Week 4	Number Analyzed	41 participants	49 participants
		0.15 (1.21)	0.43 (1.08)
Chest Pain, Week 5	Number Analyzed	39 participants	47 participants
		0.27 (1.19)	0.28 (1.00)
Chest Pain, Week 6	Number Analyzed	33 participants	48 participants
		0.30 (1.26)	0.25 (0.85)
Chest Pain, Week 7	Number Analyzed	30 participants	44 participants
		0.23 (1.04)	0.30 (0.97)
Chest Pain, Week 8	Number Analyzed	29 participants	44 participants
		0.17 (1.12)	0.20 (0.82)
Chest Pain, Week 9	Number Analyzed	31 participants	47 participants
		0.27 (1.00)	0.33 (1.07)
Chest Pain, Week 10	Number Analyzed	30 participants	40 participants
		0.30 (1.13)	0.25 (1.12)
Chest Pain, Week 11	Number Analyzed	29 participants	34 participants
		0.26 (1.32)	0.21 (0.96)
Chest Pain, Week 12	Number Analyzed	32 participants	40 participants
		0.22 (1.33)	0.33 (0.97)
Chest Pain, Week 13	Number Analyzed	28 participants	38 participants
		0.07 (1.17)	0.30 (1.04)
Chest Pain, Week 14	Number Analyzed	28 participants	35 participants
		0.07 (1.16)	0.27 (0.85)
Chest Pain, Week 15	Number Analyzed	30 participants	40 participants
		0.10 (1.23)	0.45 (1.01)
Chest Pain, Week 16	Number Analyzed	25 participants	32 participants
		0.00 (1.20)	0.19 (0.99)
Chest Pain, Week 17	Number Analyzed	27 participants	34 participants
		0.22 (1.41)	0.22 (1.20)
Chest Pain, Week 18	Number Analyzed	23 participants	37 participants
		0.11 (1.26)	0.26 (0.85)
Chest Pain, Week 19	Number Analyzed	22 participants	32 participants
		0.11 (1.01)	0.23 (0.94)
Chest Pain, Week 20	Number Analyzed	22 participants	35 participants
		0.20 (1.32)	0.23 (0.95)
Chest Pain, Week 21	Number Analyzed	18 participants	36 participants
		0.03 (0.83)	0.11 (0.87)
Chest Pain, Week 22	Number Analyzed	20 participants	35 participants
		0.30 (1.35)	0.19 (1.02)
Chest Pain, Week 23	Number Analyzed	16 participants	33 participants
		0.00 (1.00)	0.33 (0.84)
Chest Pain, Week 24	Number Analyzed	16 participants	33 participants
		-0.09 (0.88)	0.18 (1.13)
Chest Pain, Week 25	Number Analyzed	11 participants	29 participants
		0.27 (0.79)	0.29 (0.87)
Chest Pain, Week 26	Number Analyzed	13 participants	32 participants
		0.12 (1.31)	0.11 (0.72)
Chest Pain, Week 27	Number Analyzed	11 participants	32 participants
		0.05 (1.15)	0.20 (0.80)
Chest Pain, Week 28	Number Analyzed	11 participants	30 participants
		0.00 (0.81)	0.23 (0.98)
Chest Pain, Week 29	Number Analyzed	12 participants	28 participants
		-0.25 (0.87)	0.18 (0.80)
Chest Pain, Week 30	Number Analyzed	12 participants	30 participants
		0.21 (1.45)	0.32 (0.95)
Chest Pain, Week 31	Number Analyzed	11 participants	29 participants
		0.18 (1.72)	0.33 (0.90)
Chest Pain, Week 32	Number Analyzed	11 participants	23 participants
		0.41 (1.61)	0.35 (1.20)
Chest Pain, Week 33	Number Analyzed	13 participants	26 participants
		0.00 (1.44)	0.04 (1.03)
Chest Pain, Week 34	Number Analyzed	10 participants	26 participants
		0.40 (1.31)	0.31 (0.98)
Chest Pain, Week 35	Number Analyzed	11 participants	27 participants
		0.00 (1.16)	0.28 (1.13)
Chest Pain, Week 36	Number Analyzed	9 participants	25 participants
		0.06 (0.85)	0.08 (0.95)
Chest Pain, Week 37	Number Analyzed	8 participants	23 participants
		0.31 (1.25)	0.39 (0.89)
Chest Pain, Week 38	Number Analyzed	11 participants	21 participants
		0.23 (0.72)	0.31 (1.20)
Chest Pain, Week 39	Number Analyzed	9 participants	22 participants
		0.22 (1.00)	0.14 (0.92)
Chest Pain, Week 40	Number Analyzed	7 participants	23 participants
		0.43 (1.02)	0.30 (1.21)
Chest Pain, Week 41	Number Analyzed	7 participants	20 participants
		0.36 (1.07)	0.30 (1.01)
Chest Pain, Week 42	Number Analyzed	6 participants	20 participants
		0.25 (1.04)	0.33 (1.05)
Chest Pain, Week 43	Number Analyzed	5 participants	20 participants
		0.30 (1.15)	0.18 (1.29)
Chest Pain, Week 44	Number Analyzed	7 participants	19 participants
		0.14 (0.99)	0.42 (1.15)
Chest Pain, Week 45	Number Analyzed	4 participants	21 participants
		0.63 (0.48)	0.31 (0.90)
Chest Pain, Week 46	Number Analyzed	5 participants	19 participants
		0.30 (0.45)	0.37 (0.93)
Chest Pain, Week 47	Number Analyzed	4 participants	18 participants
		0.50 (0.71)	0.31 (0.86)
Chest Pain, Week 48	Number Analyzed	3 participants	15 participants
		0.50 (0.50)	0.17 (0.79)
Chest Pain, Week 49	Number Analyzed	3 participants	17 participants
		1.00 (1.32)	0.47 (1.07)
Chest Pain, Week 50	Number Analyzed	5 participants	15 participants
		0.80 (0.91)	0.20 (0.92)
Chest Pain, Week 51	Number Analyzed	4 participants	16 participants
		0.88 (0.85)	0.31 (0.89)
Chest Pain, Week 52	Number Analyzed	4 participants	13 participants
		0.75 (1.19)	0.54 (1.11)
Chest Pain, Week 53	Number Analyzed	5 participants	12 participants
		0.70 (0.84)	0.29 (1.08)
Chest Pain, Week 54	Number Analyzed	4 participants	14 participants
		1.13 (1.03)	0.25 (0.87)
Chest Pain, Week 55	Number Analyzed	3 participants	13 participants
		1.17 (1.26)	0.15 (0.99)
Chest Pain, Week 56	Number Analyzed	4 participants	14 participants
		0.38 (0.48)	0.29 (0.96)
Chest Pain, Week 57	Number Analyzed	3 participants	13 participants
		0.67 (0.58)	0.08 (0.73)
Chest Pain, Week 58	Number Analyzed	3 participants	13 participants
		1.17 (1.04)	0.19 (1.07)
Chest Pain, Week 59	Number Analyzed	3 participants	9 participants
		1.00 (0.87)	0.00 (0.87)
Chest Pain, Week 60	Number Analyzed	2 participants	13 participants
		0.50 (1.41)	0.38 (1.08)
Chest Pain, Week 61	Number Analyzed	3 participants	14 participants
		1.00 (0.87)	0.36 (1.12)
Chest Pain, Week 62	Number Analyzed	3 participants	14 participants
		0.83 (0.76)	0.43 (1.16)
Chest Pain, Week 63	Number Analyzed	2 participants	12 participants
		0.50 (0.71)	0.29 (0.86)
Chest Pain, Week 64	Number Analyzed	1 participants	10 participants
		0.00	0.40 (1.22)
Chest Pain, Week 65	Number Analyzed	1 participants	13 participants
		0.00	0.35 (1.11)
Chest Pain, Week 66	Number Analyzed	1 participants	11 participants
		0.00	0.45 (1.44)
Chest Pain, Week 67	Number Analyzed	2 participants	11 participants
		1.00 (1.41)	-0.09 (0.80)
Chest Pain, Week 68	Number Analyzed	2 participants	9 participants
		0.75 (1.06)	0.39 (1.45)
Chest Pain, Week 69	Number Analyzed	2 participants	10 participants
		0.50 (0.71)	0.50 (1.33)
Chest Pain, Week 70	Number Analyzed	2 participants	11 participants
		1.00 (1.41)	0.18 (0.81)
Chest Pain, Week 71	Number Analyzed	2 participants	10 participants
		0.50 (0.71)	0.45 (1.32)
Chest Pain, Week 72	Number Analyzed	1 participants	12 participants
		1.00	0.42 (1.18)
Chest Pain, Week 73	Number Analyzed	1 participants	11 participants
		1.50	0.27 (1.19)
Chest Pain, Week 74	Number Analyzed	2 participants	9 participants
		0.50 (0.71)	0.50 (1.30)
Chest Pain, Week 75	Number Analyzed	2 participants	9 participants
		0.75 (1.06)	0.33 (1.32)
Chest Pain, Week 76	Number Analyzed	2 participants	8 participants
		0.50 (0.71)	0.00 (0.93)
Chest Pain, Week 77	Number Analyzed	2 participants	8 participants
		0.50 (0.71)	0.19 (1.33)
Chest Pain, Week 78	Number Analyzed	2 participants	7 participants
		1.00 (1.41)	0.21 (1.44)
Chest Pain, Week 79	Number Analyzed	2 participants	8 participants
		0.50 (0.71)	0.31 (1.31)
Chest Pain, Week 80	Number Analyzed	2 participants	9 participants
		0.75 (1.06)	0.72 (1.70)
Chest Pain, Week 81	Number Analyzed	2 participants	6 participants
		0.75 (1.06)	0.08 (1.72)
Chest Pain, Week 82	Number Analyzed	1 participants	6 participants
		0.00	0.08 (1.24)
Chest Pain, Week 83	Number Analyzed	1 participants	6 participants
		0.00	0.50 (1.48)
Chest Pain, Week 84	Number Analyzed	1 participants	7 participants
		0.50	0.43 (1.43)
Chest Pain, Week 85	Number Analyzed	1 participants	8 participants
		0.00	0.38 (1.41)
Chest Pain, Week 86	Number Analyzed	1 participants	7 participants
		0.00	0.21 (1.44)
Chest Pain, Week 87	Number Analyzed	1 participants	7 participants
		0.00	0.29 (1.41)
Chest Pain, Week 88	Number Analyzed	0 participants	7 participants
			0.43 (1.17)
Chest Pain, Week 89	Number Analyzed	0 participants	5 participants
			-0.20 (0.91)
Chest Pain, Week 90	Number Analyzed	0 participants	7 participants
			0.07 (1.13)
Chest Pain, Week 91	Number Analyzed	0 participants	7 participants
			-0.07 (0.89)
Chest Pain, Week 92	Number Analyzed	0 participants	6 participants
			0.33 (1.54)
Chest Pain, Week 93	Number Analyzed	0 participants	7 participants
			0.50 (1.47)
Chest Pain, Week 94	Number Analyzed	0 participants	5 participants
			0.20 (1.35)
Chest Pain, Week 95	Number Analyzed	0 participants	6 participants
			0.33 (1.54)
Chest Pain, Week 96	Number Analyzed	0 participants	6 participants
			0.33 (1.54)
Chest Pain, Week 97	Number Analyzed	0 participants	7 participants
			0.50 (1.47)
Chest Pain, Week 98	Number Analyzed	0 participants	6 participants
			0.33 (1.54)
Chest Pain, Week 99	Number Analyzed	0 participants	4 participants
			0.88 (1.18)
Chest Pain, Week 100	Number Analyzed	0 participants	5 participants
			0.50 (1.00)
Chest Pain, Week 101	Number Analyzed	0 participants	6 participants
			0.83 (0.93)
Chest Pain, Week 102	Number Analyzed	0 participants	5 participants
			0.50 (1.00)
Chest Pain, Week 103	Number Analyzed	0 participants	4 participants
			0.63 (1.11)
Chest Pain, Week 104	Number Analyzed	0 participants	3 participants
			1.00 (1.00)
Chest Pain, Week 105	Number Analyzed	0 participants	3 participants
			1.00 (1.00)
Chest Pain, Week 106	Number Analyzed	0 participants	2 participants
			0.50 (0.71)
Chest Pain, Week 107	Number Analyzed	0 participants	3 participants
			1.00 (1.00)
Chest Pain, Week 108	Number Analyzed	0 participants	2 participants
			1.50 (0.71)
Chest Pain, Week 109	Number Analyzed	0 participants	2 participants
			1.75 (1.06)
Chest Pain, Week 110	Number Analyzed	0 participants	2 participants
			2.00 (1.41)
Chest Pain, Week 111	Number Analyzed	0 participants	2 participants
			1.50 (0.71)
Chest Pain, Week 112	Number Analyzed	0 participants	2 participants
			1.50 (0.71)
Chest Pain, Week 113	Number Analyzed	0 participants	2 participants
			1.50 (0.71)
Chest Pain, Week 114	Number Analyzed	0 participants	2 participants
			2.00 (1.41)
Chest Pain, Week 115	Number Analyzed	0 participants	2 participants
			1.75 (1.06)
Chest Pain, Week 116	Number Analyzed	0 participants	2 participants
			2.00 (1.41)
Chest Pain, Week 117	Number Analyzed	0 participants	2 participants
			2.00 (1.41)
Chest Pain, Week 118	Number Analyzed	0 participants	2 participants
			2.00 (1.41)
Chest Pain, Week 119	Number Analyzed	0 participants	2 participants
			1.75 (1.06)
Chest Pain, Week 120	Number Analyzed	0 participants	1 participants
			2.50
Chest Pain, Week 121	Number Analyzed	0 participants	1 participants
			2.00
Chest Pain, Week 122	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 123	Number Analyzed	0 participants	1 participants
			2.50
Chest Pain, Week 124	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 125	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 126	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 127	Number Analyzed	0 participants	1 participants
			2.00
Chest Pain, Week 128	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 129	Number Analyzed	0 participants	1 participants
			3.00
Chest Pain, Week 130	Number Analyzed	0 participants	1 participants
			2.00
Chest Pain, Week 131	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 1	Number Analyzed	44 participants	47 participants
		0.13 (0.86)	0.10 (0.70)
Cough, Week 2	Number Analyzed	42 participants	48 participants
		-0.01 (0.99)	0.19 (0.75)
Cough, Week 3	Number Analyzed	44 participants	49 participants
		-0.03 (0.76)	-0.01 (0.76)
Cough, Week 4	Number Analyzed	41 participants	49 participants
		-0.02 (1.02)	-0.03 (0.98)
Cough, Week 5	Number Analyzed	39 participants	47 participants
		-0.01 (0.84)	0.00 (0.96)
Cough, Week 6	Number Analyzed	33 participants	48 participants
		-0.18 (0.93)	-0.18 (0.89)
Cough, Week 7	Number Analyzed	30 participants	44 participants
		-0.20 (0.92)	-0.06 (0.98)
Cough, Week 8	Number Analyzed	29 participants	44 participants
		-0.10 (0.90)	-0.13 (0.91)
Cough, Week 9	Number Analyzed	31 participants	47 participants
		-0.24 (0.86)	-0.06 (1.01)
Cough, Week 10	Number Analyzed	30 participants	40 participants
		-0.07 (1.12)	-0.10 (1.02)
Cough, Week 11	Number Analyzed	29 participants	34 participants
		0.02 (1.24)	-0.07 (1.07)
Cough, Week 12	Number Analyzed	32 participants	40 participants
		-0.08 (1.30)	-0.09 (0.97)
Cough, Week 13	Number Analyzed	28 participants	38 participants
		-0.09 (1.22)	-0.20 (0.93)
Cough, Week 14	Number Analyzed	28 participants	35 participants
		-0.20 (1.19)	-0.07 (0.95)
Cough, Week 15	Number Analyzed	30 participants	40 participants
		-0.05 (1.35)	-0.19 (1.04)
Cough, Week 16	Number Analyzed	25 participants	32 participants
		-0.10 (1.06)	-0.19 (0.94)
Cough, Week 17	Number Analyzed	27 participants	34 participants
		-0.04 (0.99)	-0.21 (1.09)
Cough, Week 18	Number Analyzed	23 participants	37 participants
		0.02 (1.23)	-0.26 (0.93)
Cough, Week 19	Number Analyzed	22 participants	32 participants
		-0.23 (1.29)	-0.27 (0.87)
Cough, Week 20	Number Analyzed	22 participants	35 participants
		0.00 (1.33)	-0.33 (0.95)
Cough, Week 21	Number Analyzed	18 participants	36 participants
		-0.17 (1.40)	-0.19 (0.88)
Cough, Week 22	Number Analyzed	20 participants	35 participants
		-0.20 (1.32)	-0.17 (0.89)
Cough, Week 23	Number Analyzed	16 participants	33 participants
		-0.22 (1.18)	0.05 (0.90)
Cough, Week 24	Number Analyzed	16 participants	33 participants
		-0.13 (1.51)	-0.12 (0.80)
Cough, Week 25	Number Analyzed	11 participants	29 participants
		-0.45 (0.96)	0.14 (0.82)
Cough, Week 26	Number Analyzed	13 participants	32 participants
		-0.46 (1.20)	-0.03 (0.89)
Cough, Week 27	Number Analyzed	11 participants	32 participants
		-0.50 (1.22)	-0.05 (0.94)
Cough, Week 28	Number Analyzed	11 participants	30 participants
		-0.45 (0.88)	0.08 (0.84)
Cough, Week 29	Number Analyzed	12 participants	28 participants
		-0.50 (1.31)	0.05 (0.67)
Cough, Week 30	Number Analyzed	12 participants	30 participants
		-0.88 (1.13)	0.12 (0.88)
Cough, Week 31	Number Analyzed	11 participants	29 participants
		-0.86 (1.40)	0.05 (0.74)
Cough, Week 32	Number Analyzed	11 participants	23 participants
		-0.73 (1.56)	-0.04 (1.04)
Cough, Week 33	Number Analyzed	13 participants	26 participants
		-0.77 (1.13)	-0.29 (1.06)
Cough, Week 34	Number Analyzed	10 participants	26 participants
		-0.80 (1.18)	-0.02 (0.75)
Cough, Week 35	Number Analyzed	11 participants	27 participants
		-0.14 (0.95)	-0.09 (1.10)
Cough, Week 36	Number Analyzed	9 participants	25 participants
		-0.17 (0.66)	-0.36 (1.16)
Cough, Week 37	Number Analyzed	8 participants	23 participants
		-0.25 (0.89)	-0.04 (0.84)
Cough, Week 38	Number Analyzed	11 participants	21 participants
		0.05 (0.88)	-0.07 (1.11)
Cough, Week 39	Number Analyzed	9 participants	22 participants
		-0.50 (0.90)	-0.20 (0.97)
Cough, Week 40	Number Analyzed	7 participants	23 participants
		-0.36 (0.94)	-0.39 (1.23)
Cough, Week 41	Number Analyzed	7 participants	20 participants
		0.21 (0.57)	0.05 (0.84)
Cough, Week 42	Number Analyzed	6 participants	20 participants
		0.17 (0.52)	-0.20 (1.16)
Cough, Week 43	Number Analyzed	5 participants	20 participants
		0.10 (0.55)	0.03 (1.06)
Cough, Week 44	Number Analyzed	7 participants	19 participants
		0.36 (0.94)	-0.11 (1.09)
Cough, Week 45	Number Analyzed	4 participants	21 participants
		0.25 (0.50)	-0.26 (0.92)
Cough, Week 46	Number Analyzed	5 participants	19 participants
		0.10 (0.96)	0.08 (0.85)
Cough, Week 47	Number Analyzed	4 participants	18 participants
		0.50 (0.58)	-0.03 (0.90)
Cough, Week 48	Number Analyzed	3 participants	15 participants
		0.17 (0.29)	0.23 (0.68)
Cough, Week 49	Number Analyzed	3 participants	17 participants
		0.67 (0.76)	0.26 (0.85)
Cough, Week 50	Number Analyzed	5 participants	15 participants
		0.30 (0.76)	0.00 (0.85)
Cough, Week 51	Number Analyzed	4 participants	16 participants
		0.13 (0.63)	0.06 (0.93)
Cough, Week 52	Number Analyzed	4 participants	13 participants
		0.63 (0.95)	0.27 (0.97)
Cough, Week 53	Number Analyzed	5 participants	12 participants
		0.70 (0.76)	0.38 (0.71)
Cough, Week 54	Number Analyzed	4 participants	14 participants
		0.50 (0.41)	0.07 (0.70)
Cough, Week 55	Number Analyzed	3 participants	13 participants
		0.67 (0.29)	0.12 (0.94)
Cough, Week 56	Number Analyzed	4 participants	14 participants
		0.50 (0.41)	0.14 (0.97)
Cough, Week 57	Number Analyzed	3 participants	13 participants
		0.50 (0.50)	0.15 (0.66)
Cough, Week 58	Number Analyzed	3 participants	13 participants
		0.67 (0.29)	0.08 (1.00)
Cough, Week 59	Number Analyzed	3 participants	9 participants
		0.33 (0.58)	0.06 (0.63)
Cough, Week 60	Number Analyzed	2 participants	13 participants
		0.75 (0.35)	-0.04 (0.83)
Cough, Week 61	Number Analyzed	3 participants	14 participants
		0.50 (0.50)	0.00 (0.88)
Cough, Week 62	Number Analyzed	3 participants	14 participants
		0.33 (0.58)	0.14 (0.79)
Cough, Week 63	Number Analyzed	2 participants	12 participants
		0.00 (0.00)	-0.04 (0.86)
Cough, Week 64	Number Analyzed	1 participants	10 participants
		0.00	0.35 (1.00)
Cough, Week 65	Number Analyzed	1 participants	13 participants
		0.50	0.12 (0.92)
Cough, Week 66	Number Analyzed	1 participants	11 participants
		0.00	0.45 (1.21)
Cough, Week 67	Number Analyzed	2 participants	11 participants
		0.25 (0.35)	-0.09 (0.66)
Cough, Week 68	Number Analyzed	2 participants	9 participants
		0.25 (0.35)	0.61 (1.29)
Cough, Week 69	Number Analyzed	2 participants	10 participants
		0.25 (0.35)	0.50 (1.18)
Cough, Week 70	Number Analyzed	2 participants	11 participants
		0.25 (0.35)	0.23 (0.79)
Cough, Week 71	Number Analyzed	2 participants	10 participants
		0.00 (0.00)	0.55 (0.90)
Cough, Week 72	Number Analyzed	1 participants	12 participants
		-0.50	0.42 (0.93)
Cough, Week 73	Number Analyzed	1 participants	11 participants
		0.00	0.64 (1.07)
Cough, Week 74	Number Analyzed	2 participants	9 participants
		0.00 (0.00)	0.56 (1.04)
Cough, Week 75	Number Analyzed	2 participants	9 participants
		0.00 (0.71)	0.67 (1.35)
Cough, Week 76	Number Analyzed	2 participants	8 participants
		0.25 (0.35)	0.31 (1.00)
Cough, Week 77	Number Analyzed	2 participants	8 participants
		0.00 (0.00)	0.56 (1.15)
Cough, Week 78	Number Analyzed	2 participants	7 participants
		0.25 (0.35)	0.36 (1.03)
Cough, Week 79	Number Analyzed	2 participants	8 participants
		0.00 (0.00)	0.63 (1.19)
Cough, Week 80	Number Analyzed	2 participants	9 participants
		0.25 (0.35)	0.33 (0.90)
Cough, Week 81	Number Analyzed	2 participants	6 participants
		0.25 (0.35)	0.58 (1.28)
Cough, Week 82	Number Analyzed	1 participants	6 participants
		0.00	0.25 (1.08)
Cough, Week 83	Number Analyzed	1 participants	6 participants
		0.00	0.67 (1.21)
Cough, Week 84	Number Analyzed	1 participants	7 participants
		0.50	0.29 (0.95)
Cough, Week 85	Number Analyzed	1 participants	8 participants
		0.00	0.38 (1.03)
Cough, Week 86	Number Analyzed	1 participants	7 participants
		0.00	0.57 (1.24)
Cough, Week 87	Number Analyzed	1 participants	7 participants
		0.00	0.64 (1.35)
Cough, Week 88	Number Analyzed	0 participants	7 participants
			0.64 (1.14)
Cough, Week 89	Number Analyzed	0 participants	5 participants
			0.50 (1.32)
Cough, Week 90	Number Analyzed	0 participants	7 participants
			0.43 (1.10)
Cough, Week 91	Number Analyzed	0 participants	7 participants
			0.50 (1.19)
Cough, Week 92	Number Analyzed	0 participants	6 participants
			0.67 (1.21)
Cough, Week 93	Number Analyzed	0 participants	7 participants
			0.79 (1.38)
Cough, Week 94	Number Analyzed	0 participants	5 participants
			0.30 (0.97)
Cough, Week 95	Number Analyzed	0 participants	6 participants
			0.67 (1.25)
Cough, Week 96	Number Analyzed	0 participants	6 participants
			0.58 (1.20)
Cough, Week 97	Number Analyzed	0 participants	7 participants
			0.57 (1.13)
Cough, Week 98	Number Analyzed	0 participants	6 participants
			0.67 (1.25)
Cough, Week 99	Number Analyzed	0 participants	4 participants
			0.25 (0.96)
Cough, Week 100	Number Analyzed	0 participants	5 participants
			0.60 (1.14)
Cough, Week 101	Number Analyzed	0 participants	6 participants
			0.50 (1.05)
Cough, Week 102	Number Analyzed	0 participants	5 participants
			0.50 (1.00)
Cough, Week 103	Number Analyzed	0 participants	4 participants
			0.25 (0.96)
Cough, Week 104	Number Analyzed	0 participants	3 participants
			0.00 (1.00)
Cough, Week 105	Number Analyzed	0 participants	3 participants
			0.33 (1.53)
Cough, Week 106	Number Analyzed	0 participants	2 participants
			-0.50 (0.71)
Cough, Week 107	Number Analyzed	0 participants	3 participants
			0.00 (1.00)
Cough, Week 108	Number Analyzed	0 participants	2 participants
			0.00 (1.41)
Cough, Week 109	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 110	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 111	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 112	Number Analyzed	0 participants	2 participants
			0.00 (1.41)
Cough, Week 113	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 114	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 115	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 116	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 117	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 118	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 119	Number Analyzed	0 participants	2 participants
			0.50 (2.12)
Cough, Week 120	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 121	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 122	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 123	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 124	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 125	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 126	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 127	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 128	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 129	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 130	Number Analyzed	0 participants	1 participants
			2.00
Cough, Week 131	Number Analyzed	0 participants	1 participants
			2.00
Dyspnoea, Week 1	Number Analyzed	44 participants	47 participants
		0.42 (0.81)	0.12 (0.76)
Dyspnoea, Week 2	Number Analyzed	42 participants	48 participants
		0.33 (0.73)	0.29 (0.87)
Dyspnoea, Week 3	Number Analyzed	44 participants	49 participants
		0.25 (0.75)	0.25 (0.97)
Dyspnoea, Week 4	Number Analyzed	41 participants	49 participants
		0.43 (0.87)	0.28 (0.89)
Dyspnoea, Week 5	Number Analyzed	39 participants	47 participants
		0.55 (0.81)	0.21 (1.00)
Dyspnoea, Week 6	Number Analyzed	33 participants	48 participants
		0.50 (0.68)	0.21 (0.95)
Dyspnoea, Week 7	Number Analyzed	30 participants	44 participants
		0.63 (0.74)	0.32 (1.08)
Dyspnoea, Week 8	Number Analyzed	29 participants	44 participants
		0.50 (0.64)	0.25 (1.00)
Dyspnoea, Week 9	Number Analyzed	31 participants	47 participants
		0.46 (0.86)	0.34 (1.01)
Dyspnoea, Week 10	Number Analyzed	30 participants	40 participants
		0.43 (0.80)	0.49 (1.12)
Dyspnoea, Week 11	Number Analyzed	29 participants	34 participants
		0.36 (0.77)	0.24 (0.97)
Dyspnoea, Week 12	Number Analyzed	32 participants	40 participants
		0.39 (0.82)	0.35 (1.04)
Dyspnoea, Week 13	Number Analyzed	28 participants	38 participants
		0.43 (0.83)	0.23 (0.94)
Dyspnoea, Week 14	Number Analyzed	28 participants	35 participants
		0.26 (0.88)	0.26 (1.14)
Dyspnoea, Week 15	Number Analyzed	30 participants	40 participants
		0.36 (1.07)	0.39 (1.22)
Dyspnoea, Week 16	Number Analyzed	25 participants	32 participants
		0.18 (0.82)	0.26 (1.13)
Dyspnoea, Week 17	Number Analyzed	27 participants	34 participants
		0.48 (0.87)	0.16 (1.17)
Dyspnoea, Week 18	Number Analyzed	23 participants	37 participants
		0.39 (0.65)	0.21 (1.05)
Dyspnoea, Week 19	Number Analyzed	22 participants	32 participants
		0.29 (0.86)	0.33 (1.12)
Dyspnoea, Week 20	Number Analyzed	22 participants	35 participants
		0.60 (0.87)	0.23 (1.00)
Dyspnoea, Week 21	Number Analyzed	18 participants	36 participants
		0.27 (0.69)	0.40 (0.93)
Dyspnoea, Week 22	Number Analyzed	20 participants	35 participants
		0.55 (0.92)	0.22 (0.99)
Dyspnoea, Week 23	Number Analyzed	16 participants	33 participants
		0.34 (0.69)	0.38 (0.98)
Dyspnoea, Week 24	Number Analyzed	16 participants	33 participants
		0.36 (1.02)	0.42 (1.06)
Dyspnoea, Week 25	Number Analyzed	11 participants	29 participants
		0.22 (0.46)	0.50 (1.14)
Dyspnoea, Week 26	Number Analyzed	13 participants	32 participants
		0.32 (0.82)	0.28 (0.95)
Dyspnoea, Week 27	Number Analyzed	11 participants	32 participants
		0.35 (1.07)	0.37 (1.04)
Dyspnoea, Week 28	Number Analyzed	11 participants	30 participants
		0.35 (0.92)	0.45 (0.83)
Dyspnoea, Week 29	Number Analyzed	12 participants	28 participants
		0.20 (0.89)	0.38 (0.85)
Dyspnoea, Week 30	Number Analyzed	12 participants	30 participants
		0.18 (0.96)	0.54 (1.01)
Dyspnoea, Week 31	Number Analyzed	11 participants	29 participants
		0.18 (0.84)	0.41 (0.86)
Dyspnoea, Week 32	Number Analyzed	11 participants	23 participants
		0.22 (1.00)	0.58 (1.04)
Dyspnoea, Week 33	Number Analyzed	13 participants	26 participants
		0.20 (0.78)	0.36 (0.96)
Dyspnoea, Week 34	Number Analyzed	10 participants	26 participants
		0.16 (0.79)	0.28 (1.00)
Dyspnoea, Week 35	Number Analyzed	11 participants	27 participants
		0.11 (0.58)	0.27 (1.02)
Dyspnoea, Week 36	Number Analyzed	9 participants	25 participants
		0.11 (0.86)	-0.02 (1.04)
Dyspnoea, Week 37	Number Analyzed	8 participants	23 participants
		0.28 (0.63)	0.42 (1.13)
Dyspnoea, Week 38	Number Analyzed	11 participants	21 participants
		0.40 (0.76)	0.50 (1.25)
Dyspnoea, Week 39	Number Analyzed	9 participants	22 participants
		0.27 (0.81)	0.25 (0.86)
Dyspnoea, Week 40	Number Analyzed	7 participants	23 participants
		0.57 (0.76)	0.44 (1.13)
Dyspnoea, Week 41	Number Analyzed	7 participants	20 participants
		0.31 (0.58)	0.53 (1.17)
Dyspnoea, Week 42	Number Analyzed	6 participants	20 participants
		0.30 (0.55)	0.52 (1.07)
Dyspnoea, Week 43	Number Analyzed	5 participants	20 participants
		0.40 (0.57)	0.41 (1.18)
Dyspnoea, Week 44	Number Analyzed	7 participants	19 participants
		0.49 (0.60)	0.31 (1.14)
Dyspnoea, Week 45	Number Analyzed	4 participants	21 participants
		0.65 (0.38)	0.53 (1.04)
Dyspnoea, Week 46	Number Analyzed	5 participants	19 participants
		0.56 (0.71)	0.37 (0.97)
Dyspnoea, Week 47	Number Analyzed	4 participants	18 participants
		0.30 (0.68)	0.39 (0.92)
Dyspnoea, Week 48	Number Analyzed	3 participants	15 participants
		0.60 (0.72)	0.39 (0.93)
Dyspnoea, Week 49	Number Analyzed	3 participants	17 participants
		1.40 (1.20)	0.47 (0.76)
Dyspnoea, Week 50	Number Analyzed	5 participants	15 participants
		0.24 (0.59)	0.53 (0.96)
Dyspnoea, Week 51	Number Analyzed	4 participants	16 participants
		1.05 (1.02)	0.59 (1.02)
Dyspnoea, Week 52	Number Analyzed	4 participants	13 participants
		1.10 (1.01)	0.72 (1.20)
Dyspnoea, Week 53	Number Analyzed	5 participants	12 participants
		0.76 (1.28)	0.40 (1.01)
Dyspnoea, Week 54	Number Analyzed	4 participants	14 participants
		1.10 (1.16)	0.63 (1.02)
Dyspnoea, Week 55	Number Analyzed	3 participants	13 participants
		1.00 (0.53)	0.72 (1.13)
Dyspnoea, Week 56	Number Analyzed	4 participants	14 participants
		0.40 (0.86)	0.61 (1.07)
Dyspnoea, Week 57	Number Analyzed	3 participants	13 participants
		0.53 (0.61)	0.45 (1.02)
Dyspnoea, Week 58	Number Analyzed	3 participants	13 participants
		0.80 (0.53)	0.60 (1.20)
Dyspnoea, Week 59	Number Analyzed	3 participants	9 participants
		0.60 (0.72)	0.18 (1.08)
Dyspnoea, Week 60	Number Analyzed	2 participants	13 participants
		1.20 (1.13)	0.57 (0.89)
Dyspnoea, Week 61	Number Analyzed	3 participants	14 participants
		0.73 (0.76)	0.54 (1.00)
Dyspnoea, Week 62	Number Analyzed	3 participants	14 participants
		0.67 (0.83)	0.66 (1.11)
Dyspnoea, Week 63	Number Analyzed	2 participants	12 participants
		0.30 (0.42)	0.77 (0.80)
Dyspnoea, Week 64	Number Analyzed	1 participants	10 participants
		0.20	0.66 (1.07)
Dyspnoea, Week 65	Number Analyzed	1 participants	13 participants
		0.60	0.94 (1.28)
Dyspnoea, Week 66	Number Analyzed	1 participants	11 participants
		0.40	0.67 (1.31)
Dyspnoea, Week 67	Number Analyzed	2 participants	11 participants
		0.50 (0.14)	0.33 (0.87)
Dyspnoea, Week 68	Number Analyzed	2 participants	9 participants
		0.20 (0.28)	0.82 (1.56)
Dyspnoea, Week 69	Number Analyzed	2 participants	10 participants
		0.30 (0.42)	0.74 (1.11)
Dyspnoea, Week 70	Number Analyzed	2 participants	11 participants
		0.30 (0.42)	0.75 (1.16)
Dyspnoea, Week 71	Number Analyzed	2 participants	10 participants
		0.10 (0.14)	0.84 (1.19)
Dyspnoea, Week 72	Number Analyzed	1 participants	12 participants
		0.00	0.80 (1.09)
Dyspnoea, Week 73	Number Analyzed	1 participants	11 participants
		0.00	0.67 (1.11)
Dyspnoea, Week 74	Number Analyzed	2 participants	9 participants
		0.20 (0.28)	0.89 (1.35)
Dyspnoea, Week 75	Number Analyzed	2 participants	9 participants
		0.30 (0.42)	0.71 (1.31)
Dyspnoea, Week 76	Number Analyzed	1 participants	8 participants
		0.30 (0.42)	0.53 (1.05)
Dyspnoea, Week 77	Number Analyzed	2 participants	8 participants
		0.40 (0.57)	0.65 (1.55)
Dyspnoea, Week 78	Number Analyzed	2 participants	7 participants
		0.30 (0.14)	0.40 (1.11)
Dyspnoea, Week 79	Number Analyzed	2 participants	8 participants
		0.10 (0.14)	0.55 (1.25)
Dyspnoea, Week 80	Number Analyzed	2 participants	9 participants
		0.50 (0.71)	0.69 (1.43)
Dyspnoea, Week 81	Number Analyzed	2 participants	6 participants
		0.40 (0.57)	0.53 (1.53)
Dyspnoea, Week 82	Number Analyzed	1 participants	6 participants
		0.60	0.53 (1.09)
Dyspnoea, Week 83	Number Analyzed	1 participants	6 participants
		0.60	0.87 (1.28)
Dyspnoea, Week 84	Number Analyzed	1 participants	7 participants
		0.80	0.89 (1.13)
Dyspnoea, Week 85	Number Analyzed	1 participants	8 participants
		0.60	0.83 (1.27)
Dyspnoea, Week 86	Number Analyzed	1 participants	7 participants
		0.40	0.66 (1.33)
Dyspnoea, Week 87	Number Analyzed	1 participants	7 participants
		0.40	0.66 (1.23)
Dyspnoea, Week 88	Number Analyzed	0 participants	7 participants
			1.20 (1.43)
Dyspnoea, Week 89	Number Analyzed	0 participants	5 participants
			0.56 (1.05)
Dyspnoea, Week 90	Number Analyzed	0 participants	7 participants
			0.74 (1.38)
Dyspnoea, Week 91	Number Analyzed	0 participants	7 participants
			0.51 (1.00)
Dyspnoea, Week 92	Number Analyzed	0 participants	6 participants
			0.87 (1.26)
Dyspnoea, Week 93	Number Analyzed	0 participants	7 participants
			1.20 (1.39)
Dyspnoea, Week 94	Number Analyzed	0 participants	5 participants
			0.48 (0.99)
Dyspnoea, Week 95	Number Analyzed	0 participants	6 participants
			0.87 (1.32)
Dyspnoea, Week 96	Number Analyzed	0 participants	6 participants
			1.13 (1.24)
Dyspnoea, Week 97	Number Analyzed	0 participants	7 participants
			1.26 (1.35)
Dyspnoea, Week 98	Number Analyzed	0 participants	6 participants
			0.80 (1.19)
Dyspnoea, Week 99	Number Analyzed	0 participants	4 participants
			0.70 (1.58)
Dyspnoea, Week 100	Number Analyzed	0 participants	5 participants
			0.88 (1.38)
Dyspnoea, Week 101	Number Analyzed	0 participants	6 participants
			1.13 (1.54)
Dyspnoea, Week 102	Number Analyzed	0 participants	5 participants
			0.96 (1.58)
Dyspnoea, Week 103	Number Analyzed	0 participants	4 participants
			0.55 (1.68)
Dyspnoea, Week 104	Number Analyzed	0 participants	3 participants
			1.07 (1.33)
Dyspnoea, Week 105	Number Analyzed	0 participants	3 participants
			1.07 (1.33)
Dyspnoea, Week 106	Number Analyzed	0 participants	2 participants
			0.40 (0.28)
Dyspnoea, Week 107	Number Analyzed	0 participants	3 participants
			1.13 (1.63)
Dyspnoea, Week 108	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 109	Number Analyzed	0 participants	2 participants
			1.30 (1.27)
Dyspnoea, Week 110	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 111	Number Analyzed	0 participants	2 participants
			1.60 (1.41)
Dyspnoea, Week 112	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 113	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 114	Number Analyzed	0 participants	2 participants
			1.60 (1.70)
Dyspnoea, Week 115	Number Analyzed	0 participants	2 participants
			1.40 (1.41)
Dyspnoea, Week 116	Number Analyzed	0 participants	2 participants
			1.30 (1.27)
Dyspnoea, Week 117	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 118	Number Analyzed	0 participants	2 participants
			1.30 (1.27)
Dyspnoea, Week 119	Number Analyzed	0 participants	2 participants
			1.50 (1.56)
Dyspnoea, Week 120	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 121	Number Analyzed	0 participants	1 participants
			2.40
Dyspnoea, Week 122	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 123	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 124	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 125	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 126	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 127	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 128	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 129	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 130	Number Analyzed	0 participants	1 participants
			2.20
Dyspnoea, Week 131	Number Analyzed	0 participants	1 participants
			2.20

15. Secondary Outcome

Title	TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
Description	TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Time Frame	Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the TC3 or IC3-WT Populations.

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	98	107
Median (95% Confidence Interval); Unit of Measure: Months
Cough	NA [1]; (NA to NA)	NA [2]; (21.5 to NA)
Dyspnea	11.8; (6.8 to 19.5)	11.1 [3]; (7.0 to NA)
Chest pain	NA [4]; (NA to NA)	NA [4]; (NA to NA)

[1]

Median TTD is not estimable by Kaplan-Meier method due to insufficient observed events.

Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events

[2]

Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events.

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

[3]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

[4]

Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events.

Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Cough for TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.984
	Confidence Interval	(2-Sided) 95%; 0.477 to 2.030
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Dyspnea for TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.955
	Confidence Interval	(2-Sided) 95%; 0.569 to 1.604
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	Chest pain for TC3 or IC3-WT Populations
	Type of Statistical Test	Superiority
	Comments	Stratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.024
	Confidence Interval	(2-Sided) 95%; 0.472 to 2.222
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	OS in Participants With PD-L1 Expression
Description	OS is defined as the time from randomization to death from any cause.
Time Frame	From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 >=50%, SP263 >=25%, SP263 >=1% in the Intent-to-Treat Wild Type Population.

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		210	212
Median (95% Confidence Interval); Unit of Measure: Months
SP263 >=50%-WT Population	Number Analyzed	143 participants	150 participants
		16.1; (9.8 to 17.4)	19.5 [1]; (13.8 to NA)
SP263 >=25%-WT Population	Number Analyzed	168 participants	168 participants
		12.6; (9.1 to 17.0)	18.2 [1]; (13.3 to NA)
SP263 =1%-WT Population	Number Analyzed	210 participants	212 participants
		14.0; (9.8 to 16.5)	17.8; (12.8 to 23.1)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=50%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.707
	Confidence Interval	(2-Sided) 95%; 0.500 to 1.000
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=25%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.693
	Confidence Interval	(2-Sided) 95%; 0.502 to 0.956
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=1%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.768
	Confidence Interval	(2-Sided) 95%; 0.579 to 1.018
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
Description	Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)
Time Frame	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 >=50%, SP263 >=25%, SP263 >=1% in the Intent-to-Treat Wild Type Population.

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		210	212
Median (95% Confidence Interval); Unit of Measure: Months
SP263 >=50%-WT Population	Number Analyzed	143 participants	150 participants
		4.9; (4.0 to 5.6)	7.0; (5.6 to 8.7)
SP263 >=25%-WT Population	Number Analyzed	168 participants	168 participants
		4.9; (4.2 to 5.6)	6.9; (5.6 to 8.4)
SP263 >=1%-WT Population	Number Analyzed	210 participants	212 participants
		5.4; (4.4 to 5.7)	6.8; (5.5 to 8.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=50%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.674
	Confidence Interval	(2-Sided) 95%; 0.511 to 0.890
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=25%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.698
	Confidence Interval	(2-Sided) 95%; 0.539 to 0.904
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	SP263 >=1%-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.725
	Confidence Interval	(2-Sided) 95%; 0.577 to 0.910
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	OS in Participants With Blood Tumor Mutational Burden (bTMB)
Description	OS is defined as the time from randomization to death from any cause.
Time Frame	From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population.

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		83	92
Median (95% Confidence Interval); Unit of Measure: Months
bTMB >=10-WT Population	Number Analyzed	83 participants	92 participants
		10.3; (7.1 to 16.9)	11.2 [1]; (7.9 to NA)
bTMB >=16-WT Population	Number Analyzed	45 participants	42 participants
		8.5 [1]; (5.8 to NA)	13.9 [1]; (10.8 to NA)
bTMB >=20-WT Population	Number Analyzed	29 participants	27 participants
		10.5 [1]; (5.8 to NA)	17.2 [1]; (10.8 to NA)

[1]

Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=10-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.867
	Confidence Interval	(2-Sided) 95%; 0.578 to 1.301
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=16-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.748
	Confidence Interval	(2-Sided) 95%; 0.414 to 1.351
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=20-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.770
	Confidence Interval	(2-Sided) 95%; 0.362 to 1.638
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
Description	PFS according to RECIST v1.1 in the bTMB subpopulations.
Time Frame	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

Analysis was performed for participants with bTMB >=10 Intent-to-treat Wild Type Population.

Arm/Group Title		Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:		Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		83	92
Median (95% Confidence Interval); Unit of Measure: Months
bTMB >=10-WT Population	Number Analyzed	83 participants	92 participants
		4.3; (3.1 to 5.4)	5.5; (2.8 to 6.8)
bTMB >=16-WT Population	Number Analyzed	45 participants	42 participants
		4.4; (2.8 to 5.7)	6.8; (4.3 to 11.6)
bTMB >=20-WT Population	Number Analyzed	29 participants	27 participants
		5.2; (3.2 to 6.4)	6.8; (4.3 to 17.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=10-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.743
	Confidence Interval	(2-Sided) 95%; 0.525 to 1.052
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=16-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.553
	Confidence Interval	(2-Sided) 95%; 0.331 to 0.924
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine), Atezolizumab
	Comments	bTMB >=20-WT Population
	Type of Statistical Test	Superiority
	Comments	Unstratified analysis
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.560
	Confidence Interval	(2-Sided) 95%; 0.295 to 1.062
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Description	[Not Specified]
Time Frame	Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)

Outcome Measure Data

Analysis Population Description

PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.

Arm/Group Title		Atezolizumab
Arm/Group Description:		Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		256
Mean (Standard Deviation); Unit of Measure: micrograms per milliliter (μg/ mL)
Cycle 2 Day 1	Number Analyzed	256 participants
		76.7 (57.6)
Cycle 3 Day 1	Number Analyzed	215 participants
		121 (57.7)
Cycle 4 Day 1	Number Analyzed	207 participants
		154 (90.1)
Cycle 8 Day 1	Number Analyzed	145 participants
		201 (98.6)
Cycle 16 Day 1	Number Analyzed	67 participants
		213 (102)
Cycle 24 Day 1	Number Analyzed	31 participants
		245 (128)
Cycle 32 Day 1	Number Analyzed	10 participants
		276 (110)
Cycle 40 Day 1	Number Analyzed	5 participants
		252 (160)
Cycle 48 Day 1	Number Analyzed	1 participants
		555 [1] (NA)
Treatment Discontinuation Visit	Number Analyzed	100 participants
		121 (88.8)

[1]

Not estimable because there is only 1 participant.

21. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Description	[Not Specified]
Time Frame	0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)

Outcome Measure Data

Analysis Population Description

PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.

Arm/Group Title	Atezolizumab
Arm/Group Description:	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	270
Mean (Standard Deviation); Unit of Measure: micrograms per milliliter (μg/ mL)
	411 (163)

22. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Event
Description	Percentage of participants with at least one adverse event.
Time Frame	Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)

Outcome Measure Data

Analysis Population Description

Safety analyses included treated participants, defined as randomized participants who received any amount of study treatment.

Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	Atezolizumab
Arm/Group Description:	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed	263	286
Measure Type: Number; Unit of Measure: Percentage of participants
	95.1	92.3

23. Secondary Outcome

Title	Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
Description	[Not Specified]
Time Frame	Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

Outcome Measure Data

Analysis Population Description

The baseline ADA-evaluable population included participants who had a baseline ADA result and had received at least one dose of atezolizumab. The post-baseline ADA evaluable population included participants who had at least one post-baseline ADA result and had received at least one dose of atezolizumab.

Arm/Group Title		Atezolizumab
Arm/Group Description:		Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Overall Number of Participants Analyzed		282
Measure Type: Number; Unit of Measure: Percentage of participants
Baseline evaluable participants	Number Analyzed	282 participants
		1.4
Post-baseline evaluable participants	Number Analyzed	267 participants
		24.3

Adverse Events

Time Frame	From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
Adverse Event Reporting Description	All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious & other adverse events reported based on safety population, which included participants who received any amount of any study drug.
Arm/Group Title	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)		Atezolizumab
Arm/Group Description	Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).		Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
All-Cause Mortality
	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)		Atezolizumab
	Affected / at Risk (%)		Affected / at Risk (%)
Total	211/287 (73.52%)		201/285 (70.53%)
Serious Adverse Events
	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	77/263 (29.28%)		97/286 (33.92%)
Blood and lymphatic system disorders
Anaemia † 1	10/263 (3.80%)	15	1/286 (0.35%)	1
Febrile neutropenia † 1	5/263 (1.90%)	5	0/286 (0.00%)	0
Leukopenia † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Neutropenia † 1	5/263 (1.90%)	5	0/286 (0.00%)	0
Pancytopenia † 1	3/263 (1.14%)	3	0/286 (0.00%)	0
Thrombocytopenia † 1	9/263 (3.42%)	10	1/286 (0.35%)	1
Thrombocytosis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Cardiac disorders
Acute myocardial infarction † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Angina pectoris † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Atrial fibrillation † 1	1/263 (0.38%)	1	1/286 (0.35%)	2
Autoimmune myocarditis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Cardiac arrest † 1	2/263 (0.76%)	2	1/286 (0.35%)	1
Cardiac failure † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Myocardial ischaemia † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Pericardial effusion † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Supraventricular tachycardia † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Arrhythmia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Endocrine disorders
Glucocorticoid deficiency † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Eye disorders
Cataract † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Gastrointestinal disorders
Abdominal pain † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Autoimmune colitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Constipation † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Diarrhoea † 1	2/263 (0.76%)	2	0/286 (0.00%)	0
Dysphagia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Gastric haemorrhage † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Gastrointestinal haemorrhage † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Gastrointestinal motility disorder † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Ileus † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Inguinal hernia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Mechanical ileus † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Nausea † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Vomiting † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Melaena † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Pancreatitis acute † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
General disorders
Asthenia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Death † 1	3/263 (1.14%)	3	2/286 (0.70%)	2
Fatigue † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Influenza like illness † 1	0/263 (0.00%)	0	3/286 (1.05%)	3
Pyrexia † 1	0/263 (0.00%)	0	4/286 (1.40%)	5
Swelling † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Hepatobiliary disorders
Cholangitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Hepatic function abnormal † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Hepatitis † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Immune system disorders
Anaphylactic reaction † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Drug hypersensitivity † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Haemophagocytic lymphohistiocytosis † 1	0/263 (0.00%)	0	1/286 (0.35%)	2
Immune system disorder † 1	0/263 (0.00%)	0	1/286 (0.35%)	2
Infections and infestations
Abscess neck † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Bacteraemia † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Bronchitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Bronchitis bacterial † 1	1/263 (0.38%)	1	1/286 (0.35%)	2
Escherichia sepsis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Gangrene † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Gastroenteritis † 1	1/263 (0.38%)	1	2/286 (0.70%)	3
Infectious pleural effusion † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Lower respiratory tract infection † 1	3/263 (1.14%)	3	3/286 (1.05%)	3
Lung abscess † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Muscle abscess † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Mycotic endophthalmitis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Periodontitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pleural infection † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Pneumocystis jirovecii pneumonia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pneumonia † 1	14/263 (5.32%)	14	15/286 (5.24%)	25
Pneumonia bacterial † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Pulmonary sepsis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Respiratory tract infection † 1	4/263 (1.52%)	5	3/286 (1.05%)	3
Sepsis † 1	2/263 (0.76%)	2	2/286 (0.70%)	2
Subcutaneous abscess † 1	1/263 (0.38%)	2	0/286 (0.00%)	0
Tuberculosis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Upper respiratory tract infection † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Urinary tract infection † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Bacterial colitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Infection † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Influenza † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
COVID-19 pneumonia † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Post-acute COVID-19 syndrome † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Injury, poisoning and procedural complications
Femur fracture † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Fracture † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Infusion related reaction † 1	0/263 (0.00%)	0	2/286 (0.70%)	2
Radiation pneumonitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Investigations
Alanine aminotransferase increased † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Aspartate aminotransferase increased † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Blood creatinine increased † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Liver function test abnormal † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Platelet count decreased † 1	1/263 (0.38%)	2	0/286 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	2/263 (0.76%)	2	0/286 (0.00%)	0
Diabetic ketoacidosis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Hypercalcaemia † 1	0/263 (0.00%)	0	3/286 (1.05%)	3
Hyperglycaemia † 1	0/263 (0.00%)	0	3/286 (1.05%)	3
Tumour lysis syndrome † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Hyponatraemia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Fistula † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pathological fracture † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Transitional cell carcinoma † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Biliary neoplasm † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Laryngeal cancer † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pancreatic neoplasm † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Langerhans' cell histiocytosis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Nervous system disorders
Carotid arteriosclerosis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Cerebral infarction † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Cerebral ischaemia † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Generalised tonic-clonic seizure † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Neurological decompensation † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Seizure † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Product Issues
Device occlusion † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Thrombosis in device † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Psychiatric disorders
Delirium † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Renal and urinary disorders
Ketonuria † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Renal failure † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Renal impairment † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema † 1	2/263 (0.76%)	2	0/286 (0.00%)	0
Aspiration † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Chronic obstructive pulmonary disease † 1	0/263 (0.00%)	0	8/286 (2.80%)	14
Dyspnoea † 1	1/263 (0.38%)	1	2/286 (0.70%)	2
Haemoptysis † 1	4/263 (1.52%)	4	0/286 (0.00%)	0
Pleural effusion † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pneumonitis † 1	1/263 (0.38%)	1	6/286 (2.10%)	10
Pneumothorax † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Pulmonary embolism † 1	1/263 (0.38%)	1	6/286 (2.10%)	6
Respiratory distress † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Asthma † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Bronchial obstruction † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Pulmonary oedema † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Autoimmune dermatitis † 1	0/263 (0.00%)	0	1/286 (0.35%)	2
Rash † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Toxic skin eruption † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Surgical and medical procedures
Cataract operation † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Vascular disorders
Deep vein thrombosis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Extremity necrosis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Hypertensive crisis † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Superior vena cava syndrome † 1	1/263 (0.38%)	1	1/286 (0.35%)	1
Thrombophlebitis † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Varicose vein † 1	1/263 (0.38%)	1	0/286 (0.00%)	0
Aortic aneurysm rupture † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
Vein disorder † 1	0/263 (0.00%)	0	1/286 (0.35%)	1
1 Term from vocabulary, MedDRA Version 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	230/263 (87.45%)		238/286 (83.22%)
Blood and lymphatic system disorders
Anaemia † 1	120/263 (45.63%)	153	50/286 (17.48%)	73
Leukopenia † 1	21/263 (7.98%)	31	4/286 (1.40%)	6
Neutropenia † 1	71/263 (27.00%)	128	5/286 (1.75%)	7
Thrombocytopenia † 1	40/263 (15.21%)	62	8/286 (2.80%)	8
Endocrine disorders
Hypothyroidism † 1	3/263 (1.14%)	3	27/286 (9.44%)	28
Gastrointestinal disorders
Constipation † 1	58/263 (22.05%)	75	42/286 (14.69%)	48
Diarrhoea † 1	30/263 (11.41%)	39	39/286 (13.64%)	55
Nausea † 1	88/263 (33.46%)	148	42/286 (14.69%)	49
Stomatitis † 1	14/263 (5.32%)	16	12/286 (4.20%)	14
Vomiting † 1	34/263 (12.93%)	45	21/286 (7.34%)	27
General disorders
Asthenia † 1	47/263 (17.87%)	66	41/286 (14.34%)	58
Chest pain † 1	10/263 (3.80%)	10	21/286 (7.34%)	28
Fatigue † 1	47/263 (17.87%)	57	44/286 (15.38%)	47
Pyrexia † 1	25/263 (9.51%)	30	40/286 (13.99%)	58
Oedema peripheral † 1	16/263 (6.08%)	18	13/286 (4.55%)	14
Infections and infestations
Nasopharyngitis † 1	7/263 (2.66%)	8	22/286 (7.69%)	37
Pneumonia † 1	8/263 (3.04%)	8	15/286 (5.24%)	17
Investigations
Alanine aminotransferase increased † 1	16/263 (6.08%)	17	30/286 (10.49%)	34
Aspartate aminotransferase increased † 1	11/263 (4.18%)	12	29/286 (10.14%)	35
Blood creatinine increased † 1	27/263 (10.27%)	33	9/286 (3.15%)	12
Neutrophil count decreased † 1	19/263 (7.22%)	27	0/286 (0.00%)	0
Platelet count decreased † 1	21/263 (7.98%)	30	1/286 (0.35%)	1
Weight decreased † 1	15/263 (5.70%)	15	25/286 (8.74%)	27
White blood cell count decreased † 1	14/263 (5.32%)	24	3/286 (1.05%)	17
Metabolism and nutrition disorders
Decreased appetite † 1	50/263 (19.01%)	61	50/286 (17.48%)	65
Hyponatraemia † 1	12/263 (4.56%)	19	19/286 (6.64%)	29
Hyperglycaemia † 1	15/263 (5.70%)	17	12/286 (4.20%)	18
Musculoskeletal and connective tissue disorders
Arthralgia † 1	8/263 (3.04%)	8	31/286 (10.84%)	46
Back pain † 1	14/263 (5.32%)	15	26/286 (9.09%)	28
Nervous system disorders
Headache † 1	18/263 (6.84%)	20	31/286 (10.84%)	32
Dizziness † 1	14/263 (5.32%)	18	9/286 (3.15%)	9
Psychiatric disorders
Insomnia † 1	15/263 (5.70%)	16	22/286 (7.69%)	25
Respiratory, thoracic and mediastinal disorders
Cough † 1	25/263 (9.51%)	27	36/286 (12.59%)	48
Dyspnoea † 1	26/263 (9.89%)	32	41/286 (14.34%)	48
Haemoptysis † 1	9/263 (3.42%)	12	23/286 (8.04%)	25
Skin and subcutaneous tissue disorders
Alopecia † 1	16/263 (6.08%)	16	3/286 (1.05%)	3
Pruritus † 1	4/263 (1.52%)	4	25/286 (8.74%)	33
Rash † 1	8/263 (3.04%)	8	23/286 (8.04%)	26
1 Term from vocabulary, MedDRA Version 24.1; † Indicates events were collected by systematic assessment

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):

Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02409342
• Other Study ID Numbers: GO29431; 2014-003083-21 ( EudraCT Number )
• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Results First Submitted: January 26, 2021
• Results First Posted: February 18, 2021
• Last Update Posted: March 15, 2023