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A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367781
Recruitment Status : Completed
First Posted : February 20, 2015
Results First Posted : April 3, 2019
Last Update Posted : August 9, 2021
Sponsor:
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 Carcinoma, Non-Squamous Non-Small Cell Lung
Interventions Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Carboplatin
Drug: Nab-Paclitaxel
Drug: Pemetrexed
Enrollment 723
Recruitment Details  
Pre-assignment Details

Participants in this study included: histologically or cytologically confirmed, Stage IV non-squamous NSCLC; and no prior treatment for Stage IV non-squamous NSCLC.

At the time of study completion a few participants that were still on maintenance treatment with atezolizumab were moved to another study, Post-Trial Access Program, or commercial use. Therefore, the reason for discontinuation was entered "Study terminated by Sponsor" for these participants.

Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Period Title: Overall Study
Started 483 240
Completed 0 0
Not Completed 483 240
Reason Not Completed
Withdrawal by Subject             20             13
Protocol Violation             0             1
Physician Decision             7             0
Randomized in Error             5             4
Non-Compliance             1             0
Lost to Follow-up             1             2
Death             330             176
Patient Moving to Roll-Over Study             17             5
Prolonged Hospitalization             1             0
Death Prior First Dose             1             0
Administrative-Change Facility             1             0
Request From Sponsor to Withdraw Patient in Survival Follow-Up             78             29
Patient Moved to Commercial Atezolizumab Use             14             9
Study Terminated by Sponsor             3             1
Patient Admitted to Hospital & Couldn't be Dosed for Randomization             1             0
Sponsor Decision             2             0
3 Year Treatment Completed, Immunotherapy Paused, Continuing Follow-Up Planned             1             0
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin) Total
Hide Arm/Group Description Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 483 240 723
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 483 participants 240 participants 723 participants
63.8  (9.5) 64.4  (8.9) 64.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 240 participants 723 participants
Female
206
  42.7%
102
  42.5%
308
  42.6%
Male
277
  57.3%
138
  57.5%
415
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 240 participants 723 participants
Hispanic or Latino
25
   5.2%
12
   5.0%
37
   5.1%
Not Hispanic or Latino
426
  88.2%
213
  88.8%
639
  88.4%
Unknown or Not Reported
32
   6.6%
15
   6.3%
47
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 483 participants 240 participants 723 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
   2.9%
3
   1.3%
17
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
   3.7%
8
   3.3%
26
   3.6%
White
428
  88.6%
222
  92.5%
650
  89.9%
More than one race
2
   0.4%
0
   0.0%
2
   0.3%
Unknown or Not Reported
21
   4.3%
7
   2.9%
28
   3.9%
1.Primary Outcome
Title Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population
Hide Description PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
Time Frame Up to approximately 35 months after first patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 456 229
Median (95% Confidence Interval)
Unit of Measure: Months
7.0
(6.3 to 7.3)
5.5
(4.4 to 5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.639
Confidence Interval (2-Sided) 95%
0.536 to 0.763
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS) in the ITT-WT Population
Hide Description OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.
Time Frame Up to approximately 35 months after first patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 456 229
Median (95% Confidence Interval)
Unit of Measure: Months
18.6
(15.8 to 21.2)
13.9
(12.0 to 18.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0298
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.788
Confidence Interval (2-Sided) 95%
0.636 to 0.977
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
Hide Description PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 483 240
Median (95% Confidence Interval)
Unit of Measure: Months
ITT Population Number Analyzed 483 participants 240 participants
7.0
(6.3 to 7.3)
5.6
(4.5 to 5.9)
TC1/2/3 or IC1/2/3 ITT Population Number Analyzed 230 participants 111 participants
7.5
(7.0 to 9.1)
5.7
(4.5 to 6.6)
TC1/2/3 or IC1/2/3-WT ITT Population Number Analyzed 216 participants 107 participants
7.5
(7.0 to 9.0)
5.9
(4.5 to 6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments ITT Population
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.647
Confidence Interval (2-Sided) 95%
0.545 to 0.768
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3-WT ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.561
Confidence Interval (2-Sided) 95%
0.432 to 0.728
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.549
Confidence Interval (2-Sided) 95%
0.425 to 0.708
Estimation Comments [Not Specified]
4.Secondary Outcome
Title OS as Determined by the Investigator Using Recist v1.1 in the ITT Population
Hide Description OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Time Frame Up to approximately 41 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 483 240
Median (95% Confidence Interval)
Unit of Measure: Months
17.0
(14.9 to 19.7)
13.5
(11.9 to 17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0732
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.837
Confidence Interval (2-Sided) 95%
0.689 to 1.017
Estimation Comments [Not Specified]
5.Secondary Outcome
Title OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population
Hide Description OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time Frame Up to approximately 35 months after first patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1 Expression Population and PD-L1 Expression WT Population
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 230 111
Median (95% Confidence Interval)
Unit of Measure: Months
TC1/2/3 or IC1/2/3 ITT Population Number Analyzed 230 participants 111 participants
21.2
(17.3 to 28.2)
16.9
(12.5 to 22.0)
TC1/2/3 or IC1/2/3 WT ITT Population Number Analyzed 216 participants 107 participants
21.2
(18.1 to 28.2)
16.9
(12.5 to 22.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0830
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.752
Confidence Interval (2-Sided) 95%
0.545 to 1.039
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 WT ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0813
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.746
Confidence Interval (2-Sided) 95%
0.536 to 1.038
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population
Hide Description ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
Time Frame Up to approximately 41 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 452 227
Measure Type: Number
Unit of Measure: Percentage of participants
60.2 41.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rate
Estimated Value 19.21
Confidence Interval (2-Sided) 95%
11.05 to 27.37
Estimation Comments Wald with Continuity Correction
7.Secondary Outcome
Title Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
Hide Description ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 479 237
Measure Type: Number
Unit of Measure: Percentage of participants
ITT Population Number Analyzed 479 participants 237 participants
59.1 42.2
TC1/2/3 or IC1/2/3 ITT WT Population Number Analyzed 215 participants 106 participants
65.6 46.2
TC1/2/3 or IC1/2/3 ITT Population Number Analyzed 229 participants 109 participants
64.6 45.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rate
Estimated Value 16.89
Confidence Interval (2-Sided) 95%
8.90 to 24.88
Estimation Comments Wald with Continuity Correction
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT WT Population
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
1.38 to 3.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT Population
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.39 to 3.51
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population
Hide Description DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation.
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-l1 Expression WT Population
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 283 100
Median (95% Confidence Interval)
Unit of Measure: Months
ITT Population Number Analyzed 283 participants 100 participants
6.2
(5.6 to 7.9)
5.4
(4.1 to 5.8)
ITT-WT Population Number Analyzed 267 participants 93 participants
6.7
(5.6 to 8.0)
5.4
(3.9 to 5.8)
TC1/2/3 or IC1/2/3 ITT Population Number Analyzed 148 participants 49 participants
7.2
(5.7 to 9.0)
5.0
(3.2 to 6.1)
TC1/2/3 or IC1/2/3 ITT WT Population Number Analyzed 141 participants 49 participants
7.2
(5.7 to 9.0)
5.0
(3.2 to 6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.614
Confidence Interval (2-Sided) 95%
0.473 to 0.797
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments ITT-WT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.600
Confidence Interval (2-Sided) 95%
0.458 to 0.785
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.548
Confidence Interval (2-Sided) 95%
0.379 to 0.791
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments TC1/2/3 or IC1/2/3 ITT WT Population
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.551
Confidence Interval (2-Sided) 95%
0.381 to 0.798
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population
Hide Description The OS rate at the 1- and 2-year landmark time points after randomization.
Time Frame Up to 41 months after first patient enrolled, years 1 and 2 reported
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 483 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Event Free Rate (%) at Year 1 ITT WT Number Analyzed 456 participants 229 participants
62.02
(57.53 to 66.51)
54.56
(48.04 to 61.08)
Event Free Rate (%) at Year 2 ITT WT Number Analyzed 456 participants 229 participants
40.43
(35.64 to 45.22)
32.36
(25.80 to 38.92)
Event Free Rate (%) at Year 1 ITT Number Analyzed 483 participants 240 participants
61.65
(57.29 to 66.02)
54.47
(48.09 to 60.84)
Event Free Rate (%) at Year 2 ITT Number Analyzed 483 participants 240 participants
39.73
(35.10 to 44.37)
32.21
(25.79 to 38.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 1 ITT WT Population
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0647
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 7.46
Confidence Interval (2-Sided) 95%
-0.45 to 15.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 2 ITT WT Population
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0516
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 8.07
Confidence Interval (2-Sided) 95%
-0.06 to 16.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 1 ITT Population
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0683
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 7.19
Confidence Interval (2-Sided) 95%
-0.54 to 14.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 2 ITT Population
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 7.53
Confidence Interval (2-Sided) 95%
-0.39 to 15.44
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population
Hide Description The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time Frame Up to 35 months after first patient enrolled, years 1 and 2 reported
Hide Outcome Measure Data
Hide Analysis Population Description
PD-L1 Expression Population and PD-L1 Expression WT Population
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 230 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT Number Analyzed 230 participants 111 participants
68.56
(62.46 to 74.66)
61.86
(52.55 to 71.17)
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT Number Analyzed 230 participants 111 participants
44.63
(35.99 to 53.27)
35.98
(23.25 to 48.72)
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT WT Number Analyzed 216 participants 107 participants
68.84
(62.56 to 75.13)
62.51
(53.07 to 71.94)
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT WT Number Analyzed 216 participants 107 participants
44.02
(34.86 to 53.18)
35.33
(22.06 to 48.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2385
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 6.69
Confidence Interval (2-Sided) 95%
-4.44 to 17.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2710
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 8.64
Confidence Interval (2-Sided) 95%
-6.75 to 24.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2733
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 6.34
Confidence Interval (2-Sided) 95%
-5.00 to 17.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2909
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 8.69
Confidence Interval (2-Sided) 95%
-7.44 to 24.81
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population
Hide Description Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 451 228
Median (95% Confidence Interval)
Unit of Measure: Months
2.2
(1.8 to 3.1)
1.9
(1.5 to 2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin), Arm B (Nab-Paclitaxel+Carboplatin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3342
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.893
Confidence Interval (2-Sided) 95%
0.711 to 1.123
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Hide Description Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Patient-reported outcome (PRO) analysis were conducted on either the ITT-WT population or the PRO-evaluable WT population, defined as participants randomized into the ITT-WT population who completed a given PRO questionnaire at the baseline visit and at least one post-baseline visit.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 236 129
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Chest Pain, Week 1 Number Analyzed 203 participants 114 participants
0.19  (0.86) 0.14  (0.90)
Chest Pain, Week 2 Number Analyzed 204 participants 108 participants
-0.02  (0.89) 0.03  (0.91)
Chest Pain, Week 3 Number Analyzed 197 participants 106 participants
-0.05  (0.95) 0.01  (0.92)
Chest Pain, Week 4 Number Analyzed 190 participants 102 participants
-0.11  (0.95) 0.01  (1.02)
Chest Pain, Week 5 Number Analyzed 192 participants 97 participants
-0.12  (0.99) 0.00  (1.03)
Chest Pain, Week 6 Number Analyzed 182 participants 98 participants
-0.24  (1.07) 0.03  (1.03)
Chest Pain, Week 7 Number Analyzed 176 participants 87 participants
-0.23  (1.11) 0.03  (1.08)
Chest Pain, Week 8 Number Analyzed 169 participants 80 participants
-0.21  (0.99) -0.14  (1.00)
Chest Pain, Week 9 Number Analyzed 172 participants 80 participants
-0.18  (1.07) -0.01  (1.07)
Chest Pain, Week 10 Number Analyzed 166 participants 75 participants
-0.10  (1.07) -0.07  (1.01)
Chest Pain, Week 11 Number Analyzed 171 participants 78 participants
-0.11  (1.14) 0.01  (0.96)
Chest Pain, Week 12 Number Analyzed 160 participants 72 participants
-0.15  (1.09) -0.10  (1.13)
Chest Pain, Week 13 Number Analyzed 151 participants 61 participants
-0.26  (1.07) -0.03  (1.02)
Chest Pain, Week 14 Number Analyzed 144 participants 62 participants
-0.28  (1.08) -0.17  (1.18)
Chest Pain, Week 15 Number Analyzed 143 participants 51 participants
-0.26  (1.14) -0.19  (1.19)
Chest Pain, Week 16 Number Analyzed 139 participants 52 participants
-0.33  (1.11) -0.16  (1.20)
Chest Pain, Week 17 Number Analyzed 145 participants 53 participants
-0.33  (1.11) -0.14  (1.13)
Chest Pain, Week 18 Number Analyzed 136 participants 49 participants
-0.28  (1.08) -0.07  (1.13)
Chest Pain, Week 19 Number Analyzed 124 participants 45 participants
-0.28  (1.04) -0.16  (1.00)
Chest Pain, Week 20 Number Analyzed 123 participants 43 participants
-0.26  (1.03) -0.22  (1.02)
Chest Pain, Week 21 Number Analyzed 126 participants 41 participants
-0.25  (1.04) -0.32  (1.08)
Chest Pain, Week 22 Number Analyzed 116 participants 37 participants
-0.28  (1.01) -0.11  (1.03)
Chest Pain, Week 23 Number Analyzed 122 participants 35 participants
-0.24  (1.03) -0.19  (1.04)
Chest Pain, Week 24 Number Analyzed 110 participants 34 participants
-0.21  (1.01) -0.43  (1.03)
Chest Pain, Week 25 Number Analyzed 104 participants 31 participants
-0.20  (0.98) -0.24  (1.07)
Chest Pain, Week 26 Number Analyzed 109 participants 31 participants
-0.17  (1.01) -0.13  (0.91)
Chest Pain, Week 27 Number Analyzed 102 participants 27 participants
-0.22  (1.01) -0.15  (1.17)
Chest Pain, Week 28 Number Analyzed 96 participants 28 participants
-0.20  (0.98) -0.07  (0.91)
Chest Pain, Week 29 Number Analyzed 104 participants 27 participants
-0.27  (1.09) -0.04  (0.92)
Chest Pain, Week 30 Number Analyzed 100 participants 23 participants
-0.15  (1.06) -0.28  (1.12)
Chest Pain, Week 31 Number Analyzed 93 participants 25 participants
-0.16  (0.95) -0.12  (1.05)
Chest Pain, Week 32 Number Analyzed 88 participants 25 participants
-0.19  (0.89) -0.30  (1.10)
Chest Pain, Week 33 Number Analyzed 88 participants 25 participants
-0.18  (1.00) -0.18  (1.11)
Chest Pain, Week 34 Number Analyzed 85 participants 24 participants
-0.18  (1.07) -0.17  (1.18)
Chest Pain, Week 35 Number Analyzed 87 participants 20 participants
-0.10  (1.09) 0.05  (1.06)
Chest Pain, Week 36 Number Analyzed 85 participants 20 participants
-0.21  (1.08) -0.35  (1.01)
Chest Pain, Week 37 Number Analyzed 82 participants 21 participants
-0.18  (1.18) -0.10  (1.04)
Chest Pain, Week 38 Number Analyzed 83 participants 19 participants
-0.32  (1.02) -0.05  (1.01)
Chest Pain, Week 39 Number Analyzed 78 participants 18 participants
-0.28  (0.90) -0.22  (1.06)
Chest Pain, Week 40 Number Analyzed 76 participants 14 participants
-0.19  (0.87) -0.39  (0.81)
Chest Pain, Week 41 Number Analyzed 77 participants 16 participants
-0.25  (0.93) -0.19  (0.89)
Chest Pain, Week 42 Number Analyzed 70 participants 16 participants
-0.16  (1.02) -0.41  (0.74)
Chest Pain, Week 43 Number Analyzed 68 participants 16 participants
-0.24  (0.90) -0.22  (0.95)
Chest Pain, Week 44 Number Analyzed 76 participants 16 participants
-0.24  (0.95) 0.00  (0.98)
Chest Pain, Week 45 Number Analyzed 69 participants 14 participants
-0.14  (0.95) -0.07  (0.78)
Chest Pain, Week 46 Number Analyzed 71 participants 15 participants
-0.15  (0.94) -0.07  (1.03)
Chest Pain, Week 47 Number Analyzed 70 participants 13 participants
-0.22  (0.98) -0.15  (0.90)
Chest Pain, Week 48 Number Analyzed 66 participants 11 participants
-0.14  (0.91) -0.18  (0.98)
Chest Pain, Week 49 Number Analyzed 65 participants 9 participants
-0.22  (0.91) -0.72  (0.75)
Chest Pain, Week 50 Number Analyzed 70 participants 8 participants
-0.18  (0.91) -0.19  (0.70)
Chest Pain, Week 51 Number Analyzed 65 participants 10 participants
-0.13  (0.71) -0.50  (0.78)
Chest Pain, Week 52 Number Analyzed 72 participants 7 participants
-0.15  (0.83) -0.36  (0.63)
Chest Pain, Week 53 Number Analyzed 64 participants 6 participants
-0.20  (0.82) -0.33  (0.61)
Chest Pain, Week 54 Number Analyzed 65 participants 7 participants
-0.22  (0.87) -0.21  (0.70)
Chest Pain, Week 55 Number Analyzed 62 participants 5 participants
-0.34  (0.80) -0.30  (0.76)
Chest Pain, Week 56 Number Analyzed 62 participants 6 participants
-0.19  (0.95) -0.33  (0.68)
Chest Pain, Week 57 Number Analyzed 62 participants 5 participants
-0.19  (0.76) -0.40  (0.65)
Chest Pain, Week 58 Number Analyzed 56 participants 4 participants
-0.32  (0.92) -0.50  (1.15)
Chest Pain, Week 59 Number Analyzed 52 participants 4 participants
-0.25  (0.93) -0.63  (0.75)
Chest Pain, Week 60 Number Analyzed 48 participants 4 participants
-0.27  (1.03) -0.50  (1.08)
Chest Pain, Week 61 Number Analyzed 49 participants 5 participants
-0.28  (1.02) -0.20  (1.15)
Chest Pain, Week 62 Number Analyzed 41 participants 5 participants
-0.16  (1.06) -0.40  (1.47)
Chest Pain, Week 63 Number Analyzed 43 participants 5 participants
-0.12  (0.82) -0.10  (1.34)
Chest Pain, Week 64 Number Analyzed 42 participants 4 participants
-0.15  (0.83) 0.38  (1.44)
Chest Pain, Week 65 Number Analyzed 40 participants 3 participants
-0.31  (0.84) 0.17  (1.76)
Chest Pain, Week 66 Number Analyzed 38 participants 4 participants
-0.25  (0.92) 0.25  (1.19)
Chest Pain, Week 67 Number Analyzed 33 participants 4 participants
-0.18  (0.86) 0.13  (1.44)
Chest Pain, Week 68 Number Analyzed 34 participants 4 participants
-0.15  (0.93) -0.25  (1.55)
Chest Pain, Week 69 Number Analyzed 35 participants 3 participants
-0.13  (0.83) -0.17  (1.89)
Chest Pain, Week 70 Number Analyzed 36 participants 3 participants
-0.14  (0.93) 0.00  (1.80)
Chest Pain, Week 71 Number Analyzed 31 participants 3 participants
-0.10  (0.88) 0.00  (0.87)
Chest Pain, Week 72 Number Analyzed 29 participants 2 participants
-0.24  (0.85) -1.00  (0.71)
Chest Pain, Week 73 Number Analyzed 28 participants 1 participants
-0.25  (1.02) -1.50
Chest Pain, Week 74 Number Analyzed 31 participants 1 participants
-0.08  (0.93) -1.50
Chest Pain, Week 75 Number Analyzed 31 participants 1 participants
-0.21  (0.98) -1.50
Chest Pain, Week 76 Number Analyzed 29 participants 1 participants
0.03  (1.00) -1.50
Chest Pain, Week 77 Number Analyzed 26 participants 2 participants
-0.06  (0.89) -1.50  (0.00)
Chest Pain, Week 78 Number Analyzed 23 participants 1 participants
-0.04  (0.84) -1.50
Chest Pain, Week 79 Number Analyzed 19 participants 1 participants
-0.11  (1.09) -0.50
Chest Pain, Week 80 Number Analyzed 20 participants 1 participants
-0.18  (1.05) -1.50
Chest Pain, Week 81 Number Analyzed 17 participants 1 participants
-0.59  (0.96) -1.50
Chest Pain, Week 82 Number Analyzed 18 participants 1 participants
-0.39  (0.96) -1.50
Chest Pain, Week 83 Number Analyzed 22 participants 1 participants
-0.34  (0.90) -1.50
Chest Pain, Week 84 Number Analyzed 20 participants 1 participants
-0.20  (0.75) -1.50
Chest Pain, Week 85 Number Analyzed 17 participants 1 participants
-0.44  (0.97) -1.50
Chest Pain, Week 86 Number Analyzed 12 participants 1 participants
-0.38  (0.64) -1.50
Chest Pain, Week 87 Number Analyzed 15 participants 1 participants
-0.53  (1.01) -1.50
Chest Pain, Week 88 Number Analyzed 14 participants 1 participants
-0.46  (1.06) -1.50
Chest Pain, Week 89 Number Analyzed 11 participants 1 participants
-0.55  (0.96) -1.50
Chest Pain, Week 90 Number Analyzed 14 participants 1 participants
-0.18  (0.85) -1.50
Chest Pain, Week 91 Number Analyzed 11 participants 1 participants
-0.32  (1.08) -1.50
Chest Pain, Week 92 Number Analyzed 10 participants 1 participants
-0.40  (0.66) -1.50
Chest Pain, Week 93 Number Analyzed 11 participants 1 participants
-0.18  (1.08) -1.50
Chest Pain, Week 94 Number Analyzed 10 participants 0 participants
-0.30  (1.09)
Chest Pain, Week 95 Number Analyzed 10 participants 0 participants
-0.05  (1.26)
Chest Pain, Week 96 Number Analyzed 9 participants 0 participants
-0.17  (1.25)
Chest Pain, Week 97 Number Analyzed 8 participants 0 participants
-0.19  (1.31)
Chest Pain, Week 98 Number Analyzed 10 participants 0 participants
-0.25  (1.16)
Chest Pain, Week 99 Number Analyzed 7 participants 0 participants
-0.21  (1.47)
Chest Pain, Week 100 Number Analyzed 6 participants 0 participants
-0.50  (1.38)
Chest Pain, Week 101 Number Analyzed 7 participants 0 participants
-0.36  (1.38)
Chest Pain, Week 102 Number Analyzed 4 participants 0 participants
-0.75  (1.71)
Chest Pain, Week 103 Number Analyzed 6 participants 0 participants
-0.33  (1.54)
Chest Pain, Week 104 Number Analyzed 5 participants 0 participants
-0.60  (1.39)
Chest Pain, Week 105 Number Analyzed 4 participants 0 participants
-1.00  (1.41)
Chest Pain, Week 106 Number Analyzed 4 participants 0 participants
-1.00  (1.41)
Chest Pain, Week 107 Number Analyzed 4 participants 0 participants
-1.00  (1.41)
Chest Pain, Week 108 Number Analyzed 4 participants 0 participants
-0.75  (1.50)
Chest Pain, Week 109 Number Analyzed 5 participants 0 participants
-0.60  (1.52)
Chest Pain, Week 110 Number Analyzed 6 participants 0 participants
-0.42  (1.43)
Chest Pain, Week 111 Number Analyzed 5 participants 0 participants
-0.50  (1.50)
Chest Pain, Week 112 Number Analyzed 4 participants 0 participants
-0.13  (0.63)
Chest Pain, Week 113 Number Analyzed 4 participants 0 participants
0.13  (0.63)
Chest Pain, Week 114 Number Analyzed 3 participants 0 participants
0.00  (1.00)
Chest Pain, Week 115 Number Analyzed 2 participants 0 participants
0.25  (0.35)
Chest Pain, Week 116 Number Analyzed 2 participants 0 participants
0.50  (0.71)
Chest Pain, Week 117 Number Analyzed 2 participants 0 participants
0.25  (1.06)
Chest Pain, Week 118 Number Analyzed 2 participants 0 participants
-0.25  (1.06)
Chest Pain, Week 119 Number Analyzed 2 participants 0 participants
-0.25  (0.35)
Chest Pain, Week 120 Number Analyzed 2 participants 0 participants
0.00  (0.71)
Chest Pain, Week 121 Number Analyzed 2 participants 0 participants
0.00  (1.41)
Chest Pain, Week 122 Number Analyzed 2 participants 0 participants
0.00  (1.41)
Chest Pain, Week 123 Number Analyzed 2 participants 0 participants
-0.75  (1.77)
Chest Pain, Week 124 Number Analyzed 1 participants 0 participants
0.50
Chest Pain, Week 125 Number Analyzed 1 participants 0 participants
0.50
Chest Pain, Survival Follow-Up Month 1 Number Analyzed 158 participants 58 participants
0.01  (1.13) 0.22  (0.87)
Chest Pain, Survival Follow-Up Month 2 Number Analyzed 42 participants 47 participants
-0.07  (1.18) -0.16  (0.96)
Chest Pain, Survival Follow-Up Month 3 Number Analyzed 36 participants 26 participants
0.15  (1.33) -0.08  (0.87)
Chest Pain, Survival Follow-Up Month 4 Number Analyzed 23 participants 28 participants
-0.28  (1.40) -0.07  (0.79)
Chest Pain, Survival Follow-Up Month 5 Number Analyzed 22 participants 22 participants
-0.11  (1.49) -0.02  (0.65)
Chest Pain, Survival Follow-Up Month 6 Number Analyzed 15 participants 21 participants
-0.37  (1.67) 0.02  (0.78)
Cough, Week 1 Number Analyzed 203 participants 114 participants
0.08  (0.69) 0.04  (0.73)
Cough, Week 2 Number Analyzed 204 participants 108 participants
0.02  (0.78) 0.04  (0.84)
Cough, Week 3 Number Analyzed 197 participants 106 participants
0.02  (0.86) -0.09  (0.93)
Cough, Week 4 Number Analyzed 190 participants 102 participants
-0.06  (0.86) -0.10  (0.93)
Cough, Week 5 Number Analyzed 192 participants 97 participants
-0.09  (0.84) -0.09  (0.99)
Cough, Week 6 Number Analyzed 182 participants 98 participants
-0.15  (0.86) -0.08  (0.98)
Cough, Week 7 Number Analyzed 176 participants 87 participants
-0.11  (0.86) -0.06  (1.01)
Cough, Week 8 Number Analyzed 169 participants 80 participants
-0.13  (0.95) -0.21  (1.04)
Cough, Week 9 Number Analyzed 172 participants 80 participants
-0.15  (0.99) -0.13  (1.23)
Cough, Week 10 Number Analyzed 166 participants 75 participants
-0.20  (1.05) -0.07  (1.17)
Cough, Week 11 Number Analyzed 171 participants 78 participants
-0.15  (1.03) -0.15  (1.17)
Cough, Week 12 Number Analyzed 160 participants 72 participants
-0.17  (1.03) -0.11  (1.09)
Cough, Week 13 Number Analyzed 151 participants 61 participants
-0.24  (1.08) -0.04  (1.11)
Cough, Week 14 Number Analyzed 144 participants 62 participants
-0.23  (1.06) -0.18  (1.08)
Cough, Week 15 Number Analyzed 143 participants 51 participants
-0.27  (1.06) -0.05  (1.10)
Cough, Week 16 Number Analyzed 139 participants 52 participants
-0.37  (1.07) -0.25  (1.09)
Cough, Week 17 Number Analyzed 145 participants 53 participants
-0.32  (1.09) -0.21  (1.01)
Cough, Week 18 Number Analyzed 136 participants 49 participants
-0.33  (1.07) -0.33  (1.09)
Cough, Week 19 Number Analyzed 124 participants 45 participants
-0.33  (1.06) -0.40  (0.89)
Cough, Week 20 Number Analyzed 123 participants 43 participants
-0.37  (1.10) -0.31  (0.90)
Cough, Week 21 Number Analyzed 126 participants 41 participants
-0.37  (1.08) -0.33  (0.96)
Cough, Week 22 Number Analyzed 116 participants 37 participants
-0.37  (1.15) -0.24  (0.97)
Cough, Week 23 Number Analyzed 122 participants 35 participants
-0.30  (1.10) -0.41  (1.03)
Cough, Week 24 Number Analyzed 110 participants 34 participants
-0.38  (1.09) -0.54  (1.04)
Cough, Week 25 Number Analyzed 104 participants 31 participants
-0.49  (0.91) -0.47  (1.05)
Cough, Week 26 Number Analyzed 109 participants 31 participants
-0.43  (0.99) -0.34  (1.02)
Cough, Week 27 Number Analyzed 102 participants 27 participants
-0.41  (0.97) -0.48  (0.98)
Cough, Week 28 Number Analyzed 96 participants 28 participants
-0.52  (0.96) -0.43  (0.84)
Cough, Week 29 Number Analyzed 104 participants 27 participants
-0.43  (0.98) -0.46  (0.91)
Cough, Week 30 Number Analyzed 100 participants 23 participants
-0.43  (0.95) -0.46  (1.07)
Cough, Week 31 Number Analyzed 93 participants 25 participants
-0.32  (1.07) -0.38  (0.77)
Cough, Week 32 Number Analyzed 88 participants 25 participants
-0.30  (0.94) -0.12  (0.99)
Cough, Week 33 Number Analyzed 88 participants 25 participants
-0.19  (1.12) -0.52  (1.03)
Cough, Week 34 Number Analyzed 85 participants 24 participants
-0.35  (1.12) -0.33  (1.03)
Cough, Week 35 Number Analyzed 87 participants 20 participants
-0.46  (1.01) 0.00  (1.22)
Cough, Week 36 Number Analyzed 85 participants 20 participants
-0.35  (1.08) -0.20  (1.01)
Cough, Week 37 Number Analyzed 82 participants 21 participants
-0.46  (1.03) -0.45  (1.11)
Cough, Week 38 Number Analyzed 83 participants 19 participants
-0.38  (1.06) -0.03  (0.89)
Cough, Week 39 Number Analyzed 78 participants 18 participants
-0.27  (0.99) -0.17  (1.00)
Cough, Week 40 Number Analyzed 76 participants 14 participants
-0.38  (0.95) -0.50  (0.90)
Cough, Week 41 Number Analyzed 77 participants 16 participants
-0.44  (0.92) -0.22  (0.77)
Cough, Week 42 Number Analyzed 70 participants 16 participants
-0.44  (0.92) -0.41  (0.97)
Cough, Week 43 Number Analyzed 68 participants 16 participants
-0.39  (0.98) -0.13  (0.92)
Cough, Week 44 Number Analyzed 76 participants 16 participants
-0.38  (0.94) -0.16  (0.89)
Cough, Week 45 Number Analyzed 69 participants 14 participants
-0.30  (1.10) -0.14  (1.03)
Cough, Week 46 Number Analyzed 71 participants 15 participants
-0.25  (0.99) -0.03  (1.23)
Cough, Week 47 Number Analyzed 70 participants 13 participants
-0.44  (0.88) -0.12  (1.23)
Cough, Week 48 Number Analyzed 66 participants 11 participants
-0.29  (0.99) 0.14  (1.21)
Cough, Week 49 Number Analyzed 65 participants 9 participants
-0.38  (1.00) -0.56  (1.36)
Cough, Week 50 Number Analyzed 70 participants 8 participants
-0.39  (0.96) -0.19  (1.16)
Cough, Week 51 Number Analyzed 65 participants 10 participants
-0.30  (1.00) -0.40  (1.20)
Cough, Week 52 Number Analyzed 72 participants 7 participants
-0.32  (1.03) -0.21  (1.07)
Cough, Week 53 Number Analyzed 64 participants 6 participants
-0.37  (1.03) -0.17  (1.33)
Cough, Week 54 Number Analyzed 65 participants 7 participants
-0.41  (0.93) -0.07  (1.21)
Cough, Week 55 Number Analyzed 62 participants 5 participants
-0.40  (0.93) 0.10  (1.34)
Cough, Week 56 Number Analyzed 62 participants 6 participants
-0.26  (0.94) 0.17  (1.13)
Cough, Week 57 Number Analyzed 62 participants 5 participants
-0.35  (0.98) 0.00  (1.27)
Cough, Week 58 Number Analyzed 56 participants 4 participants
-0.33  (1.06) 0.13  (1.31)
Cough, Week 59 Number Analyzed 52 participants 4 participants
-0.31  (0.97) 0.13  (1.60)
Cough, Week 60 Number Analyzed 48 participants 4 participants
-0.42  (0.89) 0.38  (1.18)
Cough, Week 61 Number Analyzed 49 participants 5 participants
-0.35  (0.95) 0.80  (1.20)
Cough, Week 62 Number Analyzed 41 participants 5 participants
-0.23  (1.03) 0.50  (1.62)
Cough, Week 63 Number Analyzed 43 participants 5 participants
-0.22  (1.04) 0.50  (1.27)
Cough, Week 64 Number Analyzed 42 participants 4 participants
-0.19  (1.07) 0.00  (1.87)
Cough, Week 65 Number Analyzed 40 participants 3 participants
-0.23  (1.04) 0.83  (1.04)
Cough, Week 66 Number Analyzed 38 participants 4 participants
-0.29  (0.90) 0.63  (1.03)
Cough, Week 67 Number Analyzed 33 participants 4 participants
-0.48  (0.91) 0.38  (1.38)
Cough, Week 68 Number Analyzed 34 participants 4 participants
-0.34  (0.82) 0.13  (1.49)
Cough, Week 69 Number Analyzed 35 participants 3 participants
-0.34  (1.03) 0.17  (1.61)
Cough, Week 70 Number Analyzed 36 participants 3 participants
-0.26  (0.94) 0.17  (1.61)
Cough, Week 71 Number Analyzed 31 participants 3 participants
-0.23  (0.91) 0.33  (1.04)
Cough, Week 72 Number Analyzed 29 participants 2 participants
-0.48  (0.87) -1.50  (1.41)
Cough, Week 73 Number Analyzed 28 participants 1 participants
-0.43  (0.91) -0.50
Cough, Week 74 Number Analyzed 31 participants 1 participants
-0.42  (0.93) -0.50
Cough, Week 75 Number Analyzed 31 participants 1 participants
-0.32  (1.00) -0.50
Cough, Week 76 Number Analyzed 29 participants 1 participants
-0.31  (0.91) -0.50
Cough, Week 77 Number Analyzed 26 participants 2 participants
-0.40  (0.92) -0.50  (2.83)
Cough, Week 78 Number Analyzed 23 participants 1 participants
-0.52  (0.94) 0.00
Cough, Week 79 Number Analyzed 19 participants 1 participants
-0.08  (0.93) 1.00
Cough, Week 80 Number Analyzed 20 participants 1 participants
-0.48  (0.87) 1.00
Cough, Week 81 Number Analyzed 17 participants 1 participants
-0.44  (1.01) -0.50
Cough, Week 82 Number Analyzed 18 participants 1 participants
-0.39  (0.90) 1.00
Cough, Week 83 Number Analyzed 22 participants 1 participants
-0.25  (1.09) 0.50
Cough, Week 84 Number Analyzed 20 participants 1 participants
-0.30  (0.91) 1.00
Cough, Week 85 Number Analyzed 17 participants 1 participants
-0.32  (1.25) 1.50
Cough, Week 86 Number Analyzed 12 participants 1 participants
-0.54  (1.27) 0.00
Cough, Week 87 Number Analyzed 15 participants 1 participants
-0.33  (1.18) 0.00
Cough, Week 88 Number Analyzed 14 participants 1 participants
-0.46  (1.26) 0.00
Cough, Week 89 Number Analyzed 11 participants 1 participants
-0.36  (1.07) 0.00
Cough, Week 90 Number Analyzed 14 participants 1 participants
-0.29  (1.05) 0.00
Cough, Week 91 Number Analyzed 11 participants 1 participants
-0.27  (1.17) 0.00
Cough, Week 92 Number Analyzed 10 participants 1 participants
-0.35  (1.27) 1.00
Cough, Week 93 Number Analyzed 11 participants 1 participants
-0.55  (0.96) 0.00
Cough, Week 94 Number Analyzed 10 participants 0 participants
-0.40  (0.81)
Cough, Week 95 Number Analyzed 10 participants 0 participants
0.05  (1.23)
Cough, Week 96 Number Analyzed 9 participants 0 participants
-0.28  (1.28)
Cough, Week 97 Number Analyzed 8 participants 0 participants
-0.31  (1.19)
Cough, Week 98 Number Analyzed 10 participants 0 participants
-0.10  (0.99)
Cough, Week 99 Number Analyzed 7 participants 0 participants
-0.43  (0.98)
Cough, Week 100 Number Analyzed 6 participants 0 participants
-0.58  (0.86)
Cough, Week 101 Number Analyzed 7 participants 0 participants
-0.50  (0.96)
Cough, Week 102 Number Analyzed 4 participants 0 participants
-0.50  (0.41)
Cough, Week 103 Number Analyzed 6 participants 0 participants
-0.75  (0.42)
Cough, Week 104 Number Analyzed 5 participants 0 participants
-0.80  (0.27)
Cough, Week 105 Number Analyzed 4 participants 0 participants
-0.63  (0.48)
Cough, Week 106 Number Analyzed 4 participants 0 participants
-0.63  (0.48)
Cough, Week 107 Number Analyzed 4 participants 0 participants
-0.63  (0.48)
Cough, Week 108 Number Analyzed 4 participants 0 participants
-0.50  (0.71)
Cough, Week 109 Number Analyzed 5 participants 0 participants
-0.50  (0.50)
Cough, Week 110 Number Analyzed 6 participants 0 participants
-0.50  (0.45)
Cough, Week 111 Number Analyzed 5 participants 0 participants
-0.30  (0.84)
Cough, Week 112 Number Analyzed 4 participants 0 participants
-0.63  (0.48)
Cough, Week 113 Number Analyzed 4 participants 0 participants
-0.25  (0.65)
Cough, Week 114 Number Analyzed 3 participants 0 participants
-0.33  (0.29)
Cough, Week 115 Number Analyzed 2 participants 0 participants
0.25  (0.35)
Cough, Week 116 Number Analyzed 2 participants 0 participants
-0.25  (1.06)
Cough, Week 117 Number Analyzed 2 participants 0 participants
-0.50  (0.71)
Cough, Week 118 Number Analyzed 2 participants 0 participants
-0.25  (0.35)
Cough, Week 119 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Cough, Week 120 Number Analyzed 2 participants 0 participants
-0.25  (0.35)
Cough, Week 121 Number Analyzed 2 participants 0 participants
-0.50  (0.71)
Cough, Week 122 Number Analyzed 2 participants 0 participants
-0.50  (0.71)
Cough, Week 123 Number Analyzed 2 participants 0 participants
-0.75  (1.06)
Cough, Week 124 Number Analyzed 1 participants 0 participants
0.50
Cough, Week 125 Number Analyzed 1 participants 0 participants
0.50
Cough, Survival Follow-Up Month 1 Number Analyzed 158 participants 58 participants
-0.21  (1.05) -0.01  (0.96)
Cough, Survival Follow-Up Month 2 Number Analyzed 42 participants 47 participants
-0.07  (1.16) -0.31  (1.18)
Cough, Survival Follow-Up Month 3 Number Analyzed 36 participants 26 participants
-0.14  (1.12) -0.13  (1.32)
Cough, Survival Follow-Up Month 4 Number Analyzed 23 participants 28 participants
-0.39  (1.15) -0.45  (1.17)
Cough, Survival Follow-Up Month 5 Number Analyzed 22 participants 22 participants
-0.25  (1.44) -0.27  (1.32)
Cough, Survival Follow-Up Month 6 Number Analyzed 15 participants 21 participants
-0.23  (1.53) -0.29  (1.26)
Dyspnoea, Week 1 Number Analyzed 203 participants 114 participants
0.13  (0.76) 0.23  (0.79)
Dyspnoea, Week 2 Number Analyzed 204 participants 108 participants
0.10  (0.68) 0.31  (0.84)
Dyspnoea, Week 3 Number Analyzed 197 participants 106 participants
0.22  (0.78) 0.32  (0.76)
Dyspnoea, Week 4 Number Analyzed 190 participants 102 participants
0.23  (0.80) 0.45  (0.84)
Dyspnoea, Week 5 Number Analyzed 192 participants 97 participants
0.26  (0.84) 0.42  (0.92)
Dyspnoea, Week 6 Number Analyzed 182 participants 96 participants
0.27  (0.92) 0.51  (0.95)
Dyspnoea, Week 7 Number Analyzed 176 participants 87 participants
0.29  (0.88) 0.60  (1.00)
Dyspnoea, Week 8 Number Analyzed 169 participants 80 participants
0.32  (0.97) 0.53  (1.02)
Dyspnoea, Week 9 Number Analyzed 172 participants 80 participants
0.38  (0.95) 0.62  (1.07)
Dyspnoea, Week 10 Number Analyzed 166 participants 75 participants
0.41  (1.04) 0.75  (1.13)
Dyspnoea, Week 11 Number Analyzed 171 participants 78 participants
0.50  (1.05) 0.60  (1.06)
Dyspnoea, Week 12 Number Analyzed 160 participants 72 participants
0.47  (1.07) 0.74  (1.08)
Dyspnoea, Week 13 Number Analyzed 151 participants 61 participants
0.32  (1.00) 0.76  (1.00)
Dyspnoea, Week 14 Number Analyzed 144 participants 62 participants
0.34  (0.99) 0.61  (1.10)
Dyspnoea, Week 15 Number Analyzed 143 participants 51 participants
0.29  (1.06) 0.71  (1.02)
Dyspnoea, Week 16 Number Analyzed 139 participants 52 participants
0.22  (0.99) 0.67  (1.11)
Dyspnoea, Week 17 Number Analyzed 145 participants 53 participants
0.28  (1.10) 0.68  (1.03)
Dyspnoea, Week 18 Number Analyzed 136 participants 49 participants
0.23  (1.02) 0.62  (1.03)
Dyspnoea, Week 19 Number Analyzed 124 participants 45 participants
0.26  (1.06) 0.54  (0.95)
Dyspnoea, Week 20 Number Analyzed 123 participants 43 participants
0.24  (1.02) 0.54  (1.08)
Dyspnoea, Week 21 Number Analyzed 126 participants 41 participants
0.26  (1.04) 0.39  (1.05)
Dyspnoea, Week 22 Number Analyzed 116 participants 37 participants
0.21  (0.94) 0.41  (1.05)
Dyspnoea, Week 23 Number Analyzed 122 participants 35 participants
0.18  (0.97) 0.41  (1.06)
Dyspnoea, Week 24 Number Analyzed 110 participants 34 participants
0.22  (0.93) 0.31  (1.01)
Dyspnoea, Week 25 Number Analyzed 104 participants 31 participants
0.21  (0.88) 0.20  (0.91)
Dyspnoea, Week 26 Number Analyzed 109 participants 31 participants
0.17  (0.89) 0.30  (1.00)
Dyspnoea, Week 27 Number Analyzed 102 participants 27 participants
0.20  (1.04) 0.30  (0.92)
Dyspnoea, Week 28 Number Analyzed 96 participants 28 participants
0.16  (0.94) 0.22  (1.01)
Dyspnoea, Week 29 Number Analyzed 104 participants 27 participants
0.16  (0.92) 0.33  (0.98)
Dyspnoea, Week 30 Number Analyzed 100 participants 23 participants
0.24  (1.04) 0.27  (1.02)
Dyspnoea, Week 31 Number Analyzed 93 participants 25 participants
0.12  (0.99) 0.26  (1.04)
Dyspnoea, Week 32 Number Analyzed 88 participants 25 participants
0.20  (0.95) 0.38  (1.06)
Dyspnoea, Week 33 Number Analyzed 88 participants 25 participants
0.18  (0.98) 0.19  (1.14)
Dyspnoea, Week 34 Number Analyzed 85 participants 24 participants
0.21  (1.06) 0.30  (1.02)
Dyspnoea, Week 35 Number Analyzed 87 participants 20 participants
0.22  (1.03) 0.46  (0.96)
Dyspnoea, Week 36 Number Analyzed 85 participants 20 participants
0.21  (1.09) 0.34  (1.14)
Dyspnoea, Week 37 Number Analyzed 82 participants 21 participants
0.16  (1.13) 0.10  (1.07)
Dyspnoea, Week 38 Number Analyzed 83 participants 19 participants
0.18  (1.07) 0.51  (0.99)
Dyspnoea, Week 39 Number Analyzed 78 participants 18 participants
0.31  (1.04) 0.26  (0.83)
Dyspnoea, Week 40 Number Analyzed 76 participants 14 participants
0.31  (0.99) 0.04  (0.79)
Dyspnoea, Week 41 Number Analyzed 77 participants 16 participants
0.24  (0.99) 0.18  (0.85)
Dyspnoea, Week 42 Number Analyzed 70 participants 16 participants
0.26  (1.03) 0.08  (0.70)
Dyspnoea, Week 43 Number Analyzed 68 participants 16 participants
0.17  (1.13) 0.41  (0.91)
Dyspnoea, Week 44 Number Analyzed 76 participants 16 participants
0.22  (1.06) 0.29  (0.86)
Dyspnoea, Week 45 Number Analyzed 69 participants 14 participants
0.26  (1.09) 0.31  (0.90)
Dyspnoea, Week 46 Number Analyzed 71 participants 15 participants
0.29  (0.99) 0.47  (1.03)
Dyspnoea, Week 47 Number Analyzed 70 participants 13 participants
0.20  (1.02) 0.45  (0.85)
Dyspnoea, Week 48 Number Analyzed 66 participants 11 participants
0.32  (1.00) 0.29  (0.91)
Dyspnoea, Week 49 Number Analyzed 65 participants 9 participants
0.24  (1.04) 0.00  (1.30)
Dyspnoea, Week 50 Number Analyzed 70 participants 8 participants
0.32  (0.98) 0.43  (0.88)
Dyspnoea, Week 51 Number Analyzed 65 participants 10 participants
0.24  (0.92) 0.06  (1.04)
Dyspnoea, Week 52 Number Analyzed 72 participants 7 participants
0.27  (0.95) 0.29  (0.90)
Dyspnoea, Week 53 Number Analyzed 64 participants 6 participants
0.24  (1.00) 0.30  (0.85)
Dyspnoea, Week 54 Number Analyzed 65 participants 7 participants
0.28  (0.89) 0.40  (0.95)
Dyspnoea, Week 55 Number Analyzed 62 participants 5 participants
0.26  (0.98) 0.44  (1.02)
Dyspnoea, Week 56 Number Analyzed 62 participants 6 participants
0.26  (0.97) 0.53  (1.10)
Dyspnoea, Week 57 Number Analyzed 62 participants 5 participants
0.37  (0.95) 0.24  (1.08)
Dyspnoea, Week 58 Number Analyzed 56 participants 4 participants
0.19  (1.01) 0.35  (1.40)
Dyspnoea, Week 59 Number Analyzed 52 participants 4 participants
0.32  (0.84) 0.35  (1.40)
Dyspnoea, Week 60 Number Analyzed 48 participants 4 participants
0.35  (0.99) 0.50  (1.51)
Dyspnoea, Week 61 Number Analyzed 49 participants 5 participants
0.33  (1.03) 0.60  (1.40)
Dyspnoea, Week 62 Number Analyzed 41 participants 5 participants
0.45  (0.99) 0.72  (1.36)
Dyspnoea, Week 63 Number Analyzed 43 participants 5 participants
0.44  (1.05) 0.56  (1.35)
Dyspnoea, Week 64 Number Analyzed 42 participants 4 participants
0.36  (0.98) -0.50  (1.91)
Dyspnoea, Week 65 Number Analyzed 40 participants 3 participants
0.27  (0.97) 0.07  (1.68)
Dyspnoea, Week 66 Number Analyzed 38 participants 4 participants
0.32  (1.11) 0.50  (1.23)
Dyspnoea, Week 67 Number Analyzed 33 participants 4 participants
0.28  (0.91) 0.40  (1.36)
Dyspnoea, Week 68 Number Analyzed 34 participants 4 participants
0.35  (0.96) 0.40  (1.43)
Dyspnoea, Week 69 Number Analyzed 35 participants 3 participants
0.44  (1.02) 0.73  (1.55)
Dyspnoea, Week 70 Number Analyzed 36 participants 3 participants
0.33  (0.97) 0.73  (1.55)
Dyspnoea, Week 71 Number Analyzed 31 participants 3 participants
0.50  (0.95) 0.60  (1.51)
Dyspnoea, Week 72 Number Analyzed 29 participants 3 participants
0.17  (0.95) 0.60  (1.44)
Dyspnoea, Week 73 Number Analyzed 28 participants 2 participants
0.41  (0.96) -1.80  (1.13)
Dyspnoea, Week 74 Number Analyzed 31 participants 1 participants
0.30  (1.00) -1.00
Dyspnoea, Week 75 Number Analyzed 31 participants 1 participants
0.26  (0.89) -1.00
Dyspnoea, Week 76 Number Analyzed 29 participants 1 participants
0.23  (0.89) -1.00
Dyspnoea, Week 77 Number Analyzed 26 participants 2 participants
0.20  (0.97) -1.50  (1.56)
Dyspnoea, Week 78 Number Analyzed 23 participants 1 participants
0.31  (0.94) -1.00
Dyspnoea, Week 79 Number Analyzed 19 participants 1 participants
0.32  (0.95) -1.00
Dyspnoea, Week 80 Number Analyzed 20 participants 1 participants
0.30  (0.92) -1.00
Dyspnoea, Week 81 Number Analyzed 17 participants 1 participants
-0.12  (1.00) -0.80
Dyspnoea, Week 82 Number Analyzed 18 participants 1 participants
0.02  (1.06) -0.80
Dyspnoea, Week 83 Number Analyzed 22 participants 1 participants
0.13  (1.01) -1.00
Dyspnoea, Week 84 Number Analyzed 20 participants 1 participants
0.19  (1.00) -1.00
Dyspnoea, Week 85 Number Analyzed 17 participants 1 participants
0.05  (1.17) -0.80
Dyspnoea, Week 86 Number Analyzed 12 participants 1 participants
-0.07  (1.05) -1.00
Dyspnoea, Week 87 Number Analyzed 15 participants 1 participants
-0.11  (0.96) -1.00
Dyspnoea, Week 88 Number Analyzed 14 participants 1 participants
0.06  (1.12) -1.00
Dyspnoea, Week 89 Number Analyzed 11 participants 1 participants
0.09  (0.91) -1.00
Dyspnoea, Week 90 Number Analyzed 14 participants 1 participants
0.37  (0.83) -1.00
Dyspnoea, Week 91 Number Analyzed 11 participants 1 participants
0.33  (1.11) -1.00
Dyspnoea, Week 92 Number Analyzed 10 participants 1 participants
0.20  (1.05) -0.80
Dyspnoea, Week 93 Number Analyzed 11 participants 1 participants
0.35  (0.96) -0.80
Dyspnoea, Week 94 Number Analyzed 10 participants 0 participants
0.50  (0.93)
Dyspnoea, Week 95 Number Analyzed 10 participants 0 participants
0.48  (0.98)
Dyspnoea, Week 96 Number Analyzed 9 participants 0 participants
0.51  (1.09)
Dyspnoea, Week 97 Number Analyzed 8 participants 0 participants
0.33  (1.18)
Dyspnoea, Week 98 Number Analyzed 10 participants 0 participants
0.38  (1.05)
Dyspnoea, Week 99 Number Analyzed 7 participants 0 participants
0.11  (0.99)
Dyspnoea, Week 100 Number Analyzed 6 participants 0 participants
0.27  (1.11)
Dyspnoea, Week 101 Number Analyzed 7 participants 0 participants
0.20  (1.11)
Dyspnoea, Week 102 Number Analyzed 4 participants 0 participants
0.35  (1.06)
Dyspnoea, Week 103 Number Analyzed 6 participants 0 participants
0.47  (1.29)
Dyspnoea, Week 104 Number Analyzed 5 participants 0 participants
0.48  (1.22)
Dyspnoea, Week 105 Number Analyzed 4 participants 0 participants
-0.20  (0.71)
Dyspnoea, Week 106 Number Analyzed 4 participants 0 participants
-0.20  (0.99)
Dyspnoea, Week 107 Number Analyzed 4 participants 0 participants
-0.30  (0.62)
Dyspnoea, Week 108 Number Analyzed 4 participants 0 participants
-0.15  (0.98)
Dyspnoea, Week 109 Number Analyzed 5 participants 0 participants
0.16  (1.17)
Dyspnoea, Week 110 Number Analyzed 6 participants 0 participants
0.33  (1.00)
Dyspnoea, Week 111 Number Analyzed 5 participants 0 participants
-0.04  (0.86)
Dyspnoea, Week 112 Number Analyzed 4 participants 0 participants
0.20  (0.43)
Dyspnoea, Week 113 Number Analyzed 4 participants 0 participants
0.20  (0.67)
Dyspnoea, Week 114 Number Analyzed 3 participants 0 participants
0.40  (0.72)
Dyspnoea, Week 115 Number Analyzed 2 participants 0 participants
0.80  (0.85)
Dyspnoea, Week 116 Number Analyzed 2 participants 0 participants
0.60  (0.57)
Dyspnoea, Week 117 Number Analyzed 2 participants 0 participants
0.30  (0.14)
Dyspnoea, Week 118 Number Analyzed 2 participants 0 participants
0.30  (0.42)
Dyspnoea, Week 119 Number Analyzed 2 participants 0 participants
0.50  (0.42)
Dyspnoea, Week 120 Number Analyzed 2 participants 0 participants
0.30  (0.42)
Dyspnoea, Week 121 Number Analyzed 2 participants 0 participants
0.60  (0.57)
Dyspnoea, Week 122 Number Analyzed 2 participants 0 participants
0.60  (0.00)
Dyspnoea, Week 123 Number Analyzed 2 participants 0 participants
-0.20  (0.57)
Dyspnoea, Week 124 Number Analyzed 1 participants 0 participants
-0.20
Dyspnoea, Week 125 Number Analyzed 1 participants 0 participants
0.20
Dyspnoea, Survival Follow-Up Month 1 Number Analyzed 158 participants 58 participants
0.41  (1.11) 0.60  (1.14)
Dyspnoea, Survival Follow-Up Month 2 Number Analyzed 42 participants 47 participants
0.36  (1.20) 0.46  (1.22)
Dyspnoea, Survival Follow-Up Month 3 Number Analyzed 36 participants 26 participants
0.27  (0.96) 0.61  (1.19)
Dyspnoea, Survival Follow-Up Month 4 Number Analyzed 23 participants 28 participants
0.02  (1.11) 0.45  (0.88)
Dyspnoea, Survival Follow-Up Month 5 Number Analyzed 22 participants 22 participants
0.13  (1.24) 0.48  (1.00)
Dyspnoea, Survival Follow-Up Month 6 Number Analyzed 15 participants 21 participants
-0.09  (1.29) 0.54  (0.97)
13.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
Time Frame Up to approximately 69 months after first patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 473 232
Measure Type: Number
Unit of Measure: Percentage of participants
99.6 98.7
14.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Hide Description Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
Time Frame Up to approximately 35 months after first subject enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
The baseline ADA-evaluable population included participants who had a baseline ADA result. The post-baseline ADA-evaluable population included participants who had at least one post-baseline ADA result and who had received at least one dose of study treatment. The ADA-evaluable WT population was defined as the ADA-evaluable population excluding participants with an activating EGFR mutation or ALK translocation.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 473 96
Measure Type: Number
Unit of Measure: Perecentage of participants
Baseline Number Analyzed 473 participants 84 participants
3.1 4.8
Post-baseline Number Analyzed 446 participants 96 participants
22.4 23.5
15.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm
Hide Description Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
Time Frame Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Overall Number of Participants Analyzed 465
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1 Day 1 Number Analyzed 437 participants
392  (114)
Cycle 3 Day 1 Number Analyzed 356 participants
454  (170)
16.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel
Hide Description Predose samples will be collected on the same day of treatment administration.
Time Frame Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Overall Number of Participants Analyzed 465
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1 Day 21 Number Analyzed 416 participants
70.9  (35.1)
Cycle 2 Day 21 Number Analyzed 384 participants
111  (52.2)
Cycle 3 Day 21 Number Analyzed 352 participants
134  (57.8)
Cycle 7 Day 21 Number Analyzed 257 participants
218  (93.7)
17.Secondary Outcome
Title Plasma Concentrations of Carboplatin
Hide Description [Not Specified]
Time Frame Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 hour after carboplatin infusion (infusion duration=15 to 30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin Crossover)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 29 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Pre-dose Number Analyzed 29 participants 19 participants
NA [1]   (NA) NA [1]   (NA)
Cycle 1 Day 1 Before End of Infusion Number Analyzed 23 participants 18 participants
20,500  (7500) 17,000  (5200)
Cycle 1 Day 1 Post Infusion Number Analyzed 29 participants 18 participants
11,900  (3100) 12,400  (3800)
Cycle 3 Day 1 Pre-dose Number Analyzed 23 participants 16 participants
169  (63.8) 160  (48.8)
Cycle 3 Day 1 Before End of Infusion Number Analyzed 16 participants 14 participants
15,300  (6600) 17,800  (7550)
Cycle 3 Day 1 Post Infusion Number Analyzed 18 participants 15 participants
11,400  (3060) 13,400  (6650)
[1]
Below the level of detection.
18.Secondary Outcome
Title Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel
Hide Description [Not Specified]
Time Frame Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B (Nab-Paclitaxel+Carboplatin Crossover)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Overall Number of Participants Analyzed 30 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Pre-dose Number Analyzed 29 participants 19 participants
NA [1]   (NA) NA [1]   (NA)
Cycle 1 Day 1 Before End of Infusion Number Analyzed 27 participants 15 participants
3520  (2210) 2530  (1420)
Cycle 1 Day 1 Post Infusion Number Analyzed 25 participants 17 participants
307  (153) 417  (217)
Cycle 3 Day 1 Pre-dose Number Analyzed 23 participants 16 participants
NA [2]   (NA) NA [2]   (NA)
Cycle 3 Day 1 Before End of Infusion Number Analyzed 17 participants 10 participants
4480  (3520) 2030  (1690)
Cycle 3 Day 1 Post Infusion Number Analyzed 18 participants 15 participants
357  (253) 447  (322)
[1]
Below the level of detection.
[2]
Below the threshold of the assay.
Time Frame From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
Adverse Event Reporting Description The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
 
Arm/Group Title Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
Hide Arm/Group Description Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who did not crossover to receive atezolizumab as monotherapy. Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who crossed over to receive atezolizumab as monotherapy.
All-Cause Mortality
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   338/473 (71.46%)      108/131 (82.44%)      70/101 (69.31%)    
Hide Serious Adverse Events
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   252/473 (53.28%)      63/131 (48.09%)      24/101 (23.76%)    
Blood and lymphatic system disorders       
AGRANULOCYTOSIS  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
ANAEMIA  1  14/473 (2.96%)  16 4/131 (3.05%)  4 4/101 (3.96%)  4
FEBRILE NEUTROPENIA  1  9/473 (1.90%)  10 3/131 (2.29%)  3 2/101 (1.98%)  2
HAEMOLYTIC URAEMIC SYNDROME  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LEUKOPENIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NEUTROPENIA  1  14/473 (2.96%)  16 1/131 (0.76%)  1 1/101 (0.99%)  1
PANCYTOPENIA  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
THROMBOCYTOPENIA  1  6/473 (1.27%)  6 0/131 (0.00%)  0 0/101 (0.00%)  0
Cardiac disorders       
ACUTE CORONARY SYNDROME  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ACUTE MYOCARDIAL INFARCTION  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
ANGINA UNSTABLE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ATRIAL FIBRILLATION  1  4/473 (0.85%)  4 1/131 (0.76%)  1 0/101 (0.00%)  0
ATRIAL FLUTTER  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
BRADYCARDIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CARDIAC ANEURYSM  1  0/473 (0.00%)  0 0/131 (0.00%)  0 1/101 (0.99%)  1
CARDIAC ARREST  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
CARDIAC FAILURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CARDIAC FAILURE CHRONIC  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
CARDIAC TAMPONADE  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
CARDIO-RESPIRATORY ARREST  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
MYOCARDIAL INFARCTION  1  3/473 (0.63%)  3 1/131 (0.76%)  1 0/101 (0.00%)  0
PALPITATIONS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PERICARDIAL EFFUSION  1  6/473 (1.27%)  6 0/131 (0.00%)  0 0/101 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
VENTRICULAR TACHYCARDIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Ear and labyrinth disorders       
VERTIGO  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Endocrine disorders       
ADDISON'S DISEASE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
GLUCOCORTICOID DEFICIENCY  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPOTHYROIDISM  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
ABDOMINAL PAIN LOWER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ABDOMINAL PAIN UPPER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
COLITIS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
CONSTIPATION  1  3/473 (0.63%)  5 1/131 (0.76%)  1 0/101 (0.00%)  0
DIARRHOEA  1  14/473 (2.96%)  14 1/131 (0.76%)  1 1/101 (0.99%)  1
DUODENAL ULCER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
GASTRITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 1/101 (0.99%)  1
GASTROINTESTINAL HAEMORRHAGE  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
GASTROINTESTINAL VASCULAR MALFORMATION HAEMORRHAGIC  1  0/473 (0.00%)  0 0/131 (0.00%)  0 1/101 (0.99%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ILEUS PARALYTIC  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
IMMUNE-MEDIATED ENTEROCOLITIS  1  2/473 (0.42%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
LARGE INTESTINAL OBSTRUCTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LARGE INTESTINAL STENOSIS  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
MELAENA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NAUSEA  1  5/473 (1.06%)  5 3/131 (2.29%)  4 1/101 (0.99%)  1
OESOPHAGEAL FOOD IMPACTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  0/473 (0.00%)  0 2/131 (1.53%)  2 0/101 (0.00%)  0
STOMATITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
VOMITING  1  6/473 (1.27%)  7 3/131 (2.29%)  4 1/101 (0.99%)  1
General disorders       
ASTHENIA  1  3/473 (0.63%)  5 0/131 (0.00%)  0 0/101 (0.00%)  0
CHEST PAIN  1  5/473 (1.06%)  5 0/131 (0.00%)  0 0/101 (0.00%)  0
DEATH  1  1/473 (0.21%)  1 3/131 (2.29%)  3 0/101 (0.00%)  0
DRUG INTERACTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
FATIGUE  1  2/473 (0.42%)  2 1/131 (0.76%)  1 1/101 (0.99%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  4/473 (0.85%)  4 1/131 (0.76%)  1 1/101 (0.99%)  1
GENERALISED OEDEMA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
INFLUENZA LIKE ILLNESS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
MUCOSAL INFLAMMATION  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
OEDEMA PERIPHERAL  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
PAIN  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
PERFORMANCE STATUS DECREASED  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
PYREXIA  1  8/473 (1.69%)  9 2/131 (1.53%)  2 0/101 (0.00%)  0
SUDDEN DEATH  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Hepatobiliary disorders       
AUTOIMMUNE HEPATITIS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
BILE DUCT STONE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CHOLECYSTITIS ACUTE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CHOLESTASIS  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
HEPATIC CIRRHOSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HEPATITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HEPATOCELLULAR INJURY  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
IMMUNE-MEDIATED HEPATITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Immune system disorders       
ANAPHYLACTIC REACTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Infections and infestations       
APPENDICITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
APPENDICITIS PERFORATED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ATYPICAL PNEUMONIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
BACTERAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
BACTERIAL COLITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
BACTERIAL SEPSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
BRONCHITIS  1  6/473 (1.27%)  6 0/131 (0.00%)  0 1/101 (0.99%)  1
CAMPYLOBACTER INFECTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CELLULITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
CLOSTRIDIUM DIFFICILE INFECTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CONJUNCTIVITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CYSTITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CYTOMEGALOVIRUS COLITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
DEVICE RELATED INFECTION  1  2/473 (0.42%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
DIVERTICULITIS  1  0/473 (0.00%)  0 0/131 (0.00%)  0 1/101 (0.99%)  1
ENCEPHALITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ERYSIPELAS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
FEBRILE INFECTION  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
FURUNCLE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
GANGRENE  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
INFECTION  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
INFECTIOUS PLEURAL EFFUSION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
INFLUENZA  1  5/473 (1.06%)  5 1/131 (0.76%)  1 0/101 (0.00%)  0
NASOPHARYNGITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NEUTROPENIC INFECTION  1  0/473 (0.00%)  0 0/131 (0.00%)  0 1/101 (0.99%)  1
PARAPHARYNGEAL SPACE INFECTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PNEUMONIA  1  45/473 (9.51%)  55 13/131 (9.92%)  15 2/101 (1.98%)  2
PULMONARY SEPSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
RESPIRATORY TRACT INFECTION  1  3/473 (0.63%)  3 0/131 (0.00%)  0 1/101 (0.99%)  1
SEPSIS  1  7/473 (1.48%)  7 2/131 (1.53%)  2 0/101 (0.00%)  0
SEPTIC SHOCK  1  5/473 (1.06%)  5 2/131 (1.53%)  2 0/101 (0.00%)  0
STAPHYLOCOCCAL SEPSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
TOOTH INFECTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
TRACHEOBRONCHITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  3/473 (0.63%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
URINARY TRACT INFECTION  1  4/473 (0.85%)  4 1/131 (0.76%)  1 0/101 (0.00%)  0
UROSEPSIS  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
VASCULAR DEVICE INFECTION  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
Injury, poisoning and procedural complications       
FALL  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
FEMORAL NECK FRACTURE  1  0/473 (0.00%)  0 0/131 (0.00%)  0 1/101 (0.99%)  1
FEMUR FRACTURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
INFUSION RELATED REACTION  1  3/473 (0.63%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
LUMBAR VERTEBRAL FRACTURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PELVIC FRACTURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SPINAL COMPRESSION FRACTURE  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
SPINAL FRACTURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
UPPER LIMB FRACTURE  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
BLOOD ALKALINE PHOSPHATASE INCREASED  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
BLOOD CREATININE INCREASED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
BLOOD GLUCOSE INCREASED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LIPASE INCREASED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LYMPHOCYTE COUNT DECREASED  1  1/473 (0.21%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
NEUTROPHIL COUNT DECREASED  1  6/473 (1.27%)  6 0/131 (0.00%)  0 0/101 (0.00%)  0
PLATELET COUNT DECREASED  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
WHITE BLOOD CELL COUNT DECREASED  1  4/473 (0.85%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
Metabolism and nutrition disorders       
DECREASED APPETITE  1  0/473 (0.00%)  0 1/131 (0.76%)  1 1/101 (0.99%)  1
DEHYDRATION  1  3/473 (0.63%)  3 2/131 (1.53%)  2 0/101 (0.00%)  0
DIABETES MELLITUS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
DIABETIC KETOACIDOSIS  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
HYPERGLYCAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPERKALAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPOALBUMINAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPOCALCAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPOKALAEMIA  1  3/473 (0.63%)  5 2/131 (1.53%)  2 0/101 (0.00%)  0
HYPOMAGNESAEMIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPONATRAEMIA  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
TYPE 2 DIABETES MELLITUS  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
BACK PAIN  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
BONE PAIN  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
LUMBAR SPINAL STENOSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
MUSCULAR WEAKNESS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
MYALGIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SPINAL PAIN  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ADENOCARCINOMA OF COLON  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NON-SMALL CELL LUNG CANCER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SARCOMA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
TUMOUR PAIN  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Nervous system disorders       
ATAXIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CAROTID ARTERY STENOSIS  1  1/473 (0.21%)  1 1/131 (0.76%)  1 0/101 (0.00%)  0
CEREBROVASCULAR ACCIDENT  1  4/473 (0.85%)  4 2/131 (1.53%)  3 0/101 (0.00%)  0
DIZZINESS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
EMBOLIC STROKE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
EPILEPSY  1  2/473 (0.42%)  3 1/131 (0.76%)  1 0/101 (0.00%)  0
HEADACHE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HEMIPARESIS  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
ISCHAEMIC STROKE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LETHARGY  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PARAESTHESIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SEIZURE  1  3/473 (0.63%)  3 0/131 (0.00%)  0 0/101 (0.00%)  0
SYNCOPE  1  3/473 (0.63%)  3 1/131 (0.76%)  1 0/101 (0.00%)  0
TOXIC NEUROPATHY  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1  1/473 (0.21%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
VASOGENIC CEREBRAL OEDEMA  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
Psychiatric disorders       
CONFUSIONAL STATE  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
DISORIENTATION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
MENTAL STATUS CHANGES  1  4/473 (0.85%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
Renal and urinary disorders       
ACUTE KIDNEY INJURY  1  4/473 (0.85%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
AUTOIMMUNE NEPHRITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NEPHRITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NEPHROLITHIASIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
NEPHROPATHY TOXIC  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
POSTRENAL FAILURE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
RENAL FAILURE  1  5/473 (1.06%)  5 1/131 (0.76%)  1 1/101 (0.99%)  1
TUBULOINTERSTITIAL NEPHRITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
URINARY RETENTION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Reproductive system and breast disorders       
VAGINAL HAEMORRHAGE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE  1  3/473 (0.63%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
ASPIRATION  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ASTHMA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  13/473 (2.75%)  22 5/131 (3.82%)  8 0/101 (0.00%)  0
COUGH  1  2/473 (0.42%)  2 0/131 (0.00%)  0 1/101 (0.99%)  1
DYSPNOEA  1  12/473 (2.54%)  12 1/131 (0.76%)  1 0/101 (0.00%)  0
EPISTAXIS  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
HAEMOPTYSIS  1  6/473 (1.27%)  8 3/131 (2.29%)  4 0/101 (0.00%)  0
HYPOXIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
INTERSTITIAL LUNG DISEASE  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
LUNG DISORDER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
ORGANISING PNEUMONIA  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
OROPHARYNGEAL DISCOMFORT  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PLEURAL EFFUSION  1  8/473 (1.69%)  8 0/131 (0.00%)  0 0/101 (0.00%)  0
PNEUMONITIS  1  9/473 (1.90%)  9 2/131 (1.53%)  2 1/101 (0.99%)  1
PNEUMOTHORAX  1  1/473 (0.21%)  1 0/131 (0.00%)  0 2/101 (1.98%)  2
PNEUMOTHORAX SPONTANEOUS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
PULMONARY EMBOLISM  1  17/473 (3.59%)  18 3/131 (2.29%)  3 2/101 (1.98%)  2
PULMONARY HAEMORRHAGE  1  2/473 (0.42%)  4 0/131 (0.00%)  0 0/101 (0.00%)  0
RESPIRATORY DISTRESS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
RESPIRATORY FAILURE  1  3/473 (0.63%)  3 2/131 (1.53%)  2 0/101 (0.00%)  0
Skin and subcutaneous tissue disorders       
DRUG ERUPTION  1  0/473 (0.00%)  0 1/131 (0.76%)  1 0/101 (0.00%)  0
RASH  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
SKIN ULCER  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Surgical and medical procedures       
ABORTION INDUCED  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
Vascular disorders       
ARTERIAL OCCLUSIVE DISEASE  1  1/473 (0.21%)  1 2/131 (1.53%)  2 0/101 (0.00%)  0
DEEP VEIN THROMBOSIS  1  2/473 (0.42%)  2 0/131 (0.00%)  0 0/101 (0.00%)  0
EMBOLISM  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
FEMORAL ARTERY ANEURYSM  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
HYPOTENSION  1  2/473 (0.42%)  2 1/131 (0.76%)  1 0/101 (0.00%)  0
JUGULAR VEIN THROMBOSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
PHLEBITIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
VASCULAR STENOSIS  1  1/473 (0.21%)  1 0/131 (0.00%)  0 0/101 (0.00%)  0
1
Term from vocabulary, MedDRA version 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   467/473 (98.73%)      127/131 (96.95%)      100/101 (99.01%)    
Blood and lymphatic system disorders       
ANAEMIA  1  259/473 (54.76%)  357 67/131 (51.15%)  79 50/101 (49.50%)  55
LEUKOPENIA  1  51/473 (10.78%)  92 13/131 (9.92%)  22 6/101 (5.94%)  7
NEUTROPENIA  1  213/473 (45.03%)  424 52/131 (39.69%)  95 53/101 (52.48%)  99
THROMBOCYTOPENIA  1  132/473 (27.91%)  210 29/131 (22.14%)  49 31/101 (30.69%)  47
Ear and labyrinth disorders       
VERTIGO  1  17/473 (3.59%)  21 2/131 (1.53%)  2 7/101 (6.93%)  7
Endocrine disorders       
HYPOTHYROIDISM  1  51/473 (10.78%)  55 1/131 (0.76%)  1 0/101 (0.00%)  0
Eye disorders       
VISION BLURRED  1  25/473 (5.29%)  28 2/131 (1.53%)  2 4/101 (3.96%)  4
Gastrointestinal disorders       
ABDOMINAL PAIN  1  54/473 (11.42%)  67 9/131 (6.87%)  11 8/101 (7.92%)  9
ABDOMINAL PAIN UPPER  1  25/473 (5.29%)  33 5/131 (3.82%)  7 6/101 (5.94%)  7
CONSTIPATION  1  176/473 (37.21%)  224 38/131 (29.01%)  47 33/101 (32.67%)  42
DIARRHOEA  1  196/473 (41.44%)  321 37/131 (28.24%)  61 35/101 (34.65%)  41
DRY MOUTH  1  24/473 (5.07%)  24 3/131 (2.29%)  3 2/101 (1.98%)  2
DYSPEPSIA  1  33/473 (6.98%)  34 2/131 (1.53%)  2 5/101 (4.95%)  6
GASTROOESOPHAGEAL REFLUX DISEASE  1  24/473 (5.07%)  25 2/131 (1.53%)  3 4/101 (3.96%)  4
NAUSEA  1  236/473 (49.89%)  354 61/131 (46.56%)  85 44/101 (43.56%)  65
STOMATITIS  1  40/473 (8.46%)  45 8/131 (6.11%)  9 4/101 (3.96%)  5
VOMITING  1  130/473 (27.48%)  228 25/131 (19.08%)  38 18/101 (17.82%)  30
General disorders       
ASTHENIA  1  89/473 (18.82%)  133 19/131 (14.50%)  26 21/101 (20.79%)  29
CHEST PAIN  1  33/473 (6.98%)  43 10/131 (7.63%)  10 2/101 (1.98%)  2
CHILLS  1  25/473 (5.29%)  32 4/131 (3.05%)  4 3/101 (2.97%)  4
FATIGUE  1  228/473 (48.20%)  297 57/131 (43.51%)  73 52/101 (51.49%)  61
MUCOSAL INFLAMMATION  1  24/473 (5.07%)  26 4/131 (3.05%)  5 4/101 (3.96%)  4
OEDEMA PERIPHERAL  1  71/473 (15.01%)  81 14/131 (10.69%)  17 11/101 (10.89%)  13
PAIN  1  30/473 (6.34%)  33 6/131 (4.58%)  7 2/101 (1.98%)  3
PYREXIA  1  80/473 (16.91%)  104 12/131 (9.16%)  16 10/101 (9.90%)  15
Infections and infestations       
BRONCHITIS  1  29/473 (6.13%)  30 2/131 (1.53%)  2 4/101 (3.96%)  5
NASOPHARYNGITIS  1  38/473 (8.03%)  61 4/131 (3.05%)  4 6/101 (5.94%)  7
PNEUMONIA  1  37/473 (7.82%)  41 6/131 (4.58%)  6 2/101 (1.98%)  2
UPPER RESPIRATORY TRACT INFECTION  1  35/473 (7.40%)  55 8/131 (6.11%)  9 4/101 (3.96%)  6
URINARY TRACT INFECTION  1  63/473 (13.32%)  91 9/131 (6.87%)  9 10/101 (9.90%)  11
Injury, poisoning and procedural complications       
FALL  1  24/473 (5.07%)  33 4/131 (3.05%)  4 0/101 (0.00%)  0
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  26/473 (5.50%)  42 9/131 (6.87%)  13 5/101 (4.95%)  5
BLOOD CREATININE INCREASED  1  27/473 (5.71%)  32 7/131 (5.34%)  11 1/101 (0.99%)  2
NEUTROPHIL COUNT DECREASED  1  93/473 (19.66%)  188 18/131 (13.74%)  33 17/101 (16.83%)  29
PLATELET COUNT DECREASED  1  108/473 (22.83%)  179 22/131 (16.79%)  29 16/101 (15.84%)  32
WEIGHT DECREASED  1  63/473 (13.32%)  71 15/131 (11.45%)  16 13/101 (12.87%)  13
WHITE BLOOD CELL COUNT DECREASED  1  49/473 (10.36%)  80 9/131 (6.87%)  16 9/101 (8.91%)  12
ASPARTATE AMINOTRANSFERASE INCREASED  1  20/473 (4.23%)  30 8/131 (6.11%)  10 1/101 (0.99%)  1
Metabolism and nutrition disorders       
DECREASED APPETITE  1  144/473 (30.44%)  169 34/131 (25.95%)  36 30/101 (29.70%)  34
DEHYDRATION  1  52/473 (10.99%)  73 17/131 (12.98%)  27 8/101 (7.92%)  8
HYPOKALAEMIA  1  77/473 (16.28%)  98 12/131 (9.16%)  13 12/101 (11.88%)  16
HYPOMAGNESAEMIA  1  94/473 (19.87%)  130 23/131 (17.56%)  27 17/101 (16.83%)  23
HYPONATRAEMIA  1  31/473 (6.55%)  54 8/131 (6.11%)  10 0/101 (0.00%)  0
HYPOPHOSPHATAEMIA  1  20/473 (4.23%)  32 7/131 (5.34%)  8 1/101 (0.99%)  1
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  113/473 (23.89%)  161 19/131 (14.50%)  20 17/101 (16.83%)  20
BACK PAIN  1  89/473 (18.82%)  105 9/131 (6.87%)  9 7/101 (6.93%)  7
MUSCULAR WEAKNESS  1  25/473 (5.29%)  27 8/131 (6.11%)  10 6/101 (5.94%)  6
MYALGIA  1  50/473 (10.57%)  60 5/131 (3.82%)  5 5/101 (4.95%)  7
PAIN IN EXTREMITY  1  61/473 (12.90%)  72 7/131 (5.34%)  7 8/101 (7.92%)  8
Nervous system disorders       
DIZZINESS  1  78/473 (16.49%)  90 14/131 (10.69%)  21 11/101 (10.89%)  15
DYSGEUSIA  1  43/473 (9.09%)  46 5/131 (3.82%)  5 7/101 (6.93%)  7
HEADACHE  1  85/473 (17.97%)  106 12/131 (9.16%)  13 11/101 (10.89%)  13
NEUROPATHY PERIPHERAL  1  56/473 (11.84%)  58 13/131 (9.92%)  16 9/101 (8.91%)  10
PARAESTHESIA  1  43/473 (9.09%)  51 7/131 (5.34%)  7 5/101 (4.95%)  6
PERIPHERAL SENSORY NEUROPATHY  1  60/473 (12.68%)  71 10/131 (7.63%)  14 13/101 (12.87%)  15
Psychiatric disorders       
ANXIETY  1  32/473 (6.77%)  32 4/131 (3.05%)  4 3/101 (2.97%)  3
DEPRESSION  1  29/473 (6.13%)  29 5/131 (3.82%)  5 0/101 (0.00%)  0
INSOMNIA  1  70/473 (14.80%)  76 15/131 (11.45%)  17 16/101 (15.84%)  16
Respiratory, thoracic and mediastinal disorders       
COUGH  1  135/473 (28.54%)  162 21/131 (16.03%)  21 18/101 (17.82%)  21
DYSPNOEA  1  134/473 (28.33%)  181 28/131 (21.37%)  30 23/101 (22.77%)  29
EPISTAXIS  1  69/473 (14.59%)  84 17/131 (12.98%)  18 10/101 (9.90%)  12
HAEMOPTYSIS  1  30/473 (6.34%)  42 6/131 (4.58%)  6 2/101 (1.98%)  2
PNEUMONITIS  1  24/473 (5.07%)  26 0/131 (0.00%)  0 0/101 (0.00%)  0
PRODUCTIVE COUGH  1  35/473 (7.40%)  44 4/131 (3.05%)  4 4/101 (3.96%)  4
Skin and subcutaneous tissue disorders       
ALOPECIA  1  152/473 (32.14%)  155 33/131 (25.19%)  33 30/101 (29.70%)  30
DRY SKIN  1  28/473 (5.92%)  31 6/131 (4.58%)  6 6/101 (5.94%)  6
PRURITUS  1  61/473 (12.90%)  81 7/131 (5.34%)  7 5/101 (4.95%)  5
RASH  1  73/473 (15.43%)  86 6/131 (4.58%)  7 11/101 (10.89%)  12
RASH MACULO-PAPULAR  1  20/473 (4.23%)  21 7/131 (5.34%)  8 1/101 (0.99%)  2
Vascular disorders       
HYPERTENSION  1  26/473 (5.50%)  33 3/131 (2.29%)  4 5/101 (4.95%)  6
HYPOTENSION  1  34/473 (7.19%)  43 6/131 (4.58%)  8 7/101 (6.93%)  7
1
Term from vocabulary, MedDRA version 23.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02367781    
Other Study ID Numbers: GO29537
2014-003206-32 ( EudraCT Number )
First Submitted: February 13, 2015
First Posted: February 20, 2015
Results First Submitted: March 13, 2019
Results First Posted: April 3, 2019
Last Update Posted: August 9, 2021