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A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (BIRCH)

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ClinicalTrials.gov Identifier: NCT02031458
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : March 23, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Atezolizumab
Enrollment 667
Recruitment Details  
Pre-assignment Details Screening was performed from Day -28 to Day -1.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab
Hide Arm/Group Description Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
Period Title: Overall Study
Started 139 267 253
Completed 0 0 0
Not Completed 139 267 253
Reason Not Completed
Death             36             87             100
Protocol Violation             7             4             0
Physician Decision             0             1             0
Unknown Reason             0             1             2
Withdrawal by Subject             6             9             3
On Survival Follow-Up             46             83             73
On Treatment             43             81             73
Lost to Follow-up             1             1             2
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Total
Hide Arm/Group Description Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. Total of all reporting groups
Overall Number of Baseline Participants 139 267 253 659
Hide Baseline Analysis Population Description
Efficacy evaluable population included all enrolled participants who received any dose of the study drug (atezolizumab) during the study treatment period.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 267 participants 253 participants 659 participants
66.7  (10.4) 62.4  (10.2) 63.6  (9.3) 63.7  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 267 participants 253 participants 659 participants
Female
68
  48.9%
103
  38.6%
100
  39.5%
271
  41.1%
Male
71
  51.1%
164
  61.4%
153
  60.5%
388
  58.9%
1.Primary Outcome
Title Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF)
Hide Description ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm); PR:greater than (>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell [TC]3 [TC3] or tumor-infiltrating immune cell [IC] 3 [IC3], TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 Responders (n= 65, 122, 115, 237)
26.2
(16.0 to 38.5)
23.8
(16.5 to 32.3)
27.0
(19.1 to 36.0)
25.35
(19.9 to 31.4)
TC3 or IC2/3 Responders (n= 123, 247, 236, 483)
21.1
(14.3 to 29.4)
17.4
(12.9 to 22.7)
18.2
(13.5 to 23.8)
17.8
(14.5 to 21.5)
TC2/3 or IC2/3 Responders (n= 139, 267, 253, 520)
19.4
(13.2 to 27.0)
17.2
(12.9 to 22.3)
17.4
(12.9 to 22.6)
17.3
(14.2 to 20.8)
2.Secondary Outcome
Title Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)
Hide Description ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 Responders (n= 65, 122, 115, 237)
30.8
(19.9 to 43.5)
24.6
(17.3 to 33.2)
28.7
(20.7 to 37.9)
26.6
(21.1 to 32.7)
TC3 or IC2/3 Responders (n= 123, 247, 236, 483)
24.4
(17.1 to 33.0)
19.4
(14.7 to 24.9)
19.1
(14.3 to 24.7)
19.3
(15.8 to 23.1)
TC2/3 or IC2/3 Responders (n= 139, 267, 253, 520)
22.3
(15.7 to 30.1)
18.7
(14.2 to 23.9)
18.2
(13.6 to 23.5)
18.5
(15.2 to 22.1)
3.Secondary Outcome
Title Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV
Hide Description ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n= number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 Responders (n= 65, 122, 115, 237)
20.0
(11.1 to 31.8)
27.0
(19.4 to 35.8)
30.4
(22.2 to 39.7)
28.7
(23.0 to 34.9)
TC3 or IC2/3 Responders (n= 123, 247, 236, 483)
16.3
(10.2 to 24.0)
21.9
(16.9 to 27.5)
20.8
(15.8 to 26.5)
21.3
(17.8 to 25.3)
TC2/3 or IC2/3 Responders (n= 139, 267, 253, 520)
15.8
(10.2 to 23.0)
21.0
(16.3 to 26.4)
19.8
(15.0 to 25.2)
20.4
(17.0 to 24.1)
4.Secondary Outcome
Title Duration of Response (DOR) Assessed by IRF Per RECIST v1.1
Hide Description DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 27 46 44 90
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 DOR (n= 17, 29, 31, 60)
NA [1] 
(5.8 to NA)
NA [1] 
(4.9 to NA)
7.2 [2] 
(5.6 to NA)
7.2 [2] 
(5.7 to NA)
TC3 or IC2/3 DOR (n = 26, 43, 43, 86)
8.5 [2] 
(5.6 to NA)
8.4 [2] 
(6.9 to NA)
8.4 [2] 
(5.7 to NA)
8.4 [2] 
(6.9 to NA)
TC2/3 or IC2/3 DOR (n= 27, 46, 44, 90)
8.5 [2] 
(5.6 to NA)
8.4 [2] 
(6.9 to NA)
8.4 [2] 
(5.7 to NA)
8.4 [2] 
(6.9 to NA)
[1]
Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
[2]
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
5.Secondary Outcome
Title DOR as Assessed by INV Per RECIST v1.1
Hide Description DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 81 128 124 252
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 DOR (n= 20, 30, 33, 63)
8.5
(5.6 to 8.5)
NA [1] 
(8.1 to NA)
8.4 [2] 
(6.4 to NA)
NA [2] 
(7.4 to NA)
TC3 or IC2/3 DOR (n = 30, 48, 45, 93)
8.5 [2] 
(8.5 to NA)
NA [1] 
(NA to NA)
8.3 [2] 
(7.0 to NA)
NA [1] 
(8.3 to NA)
TC2/3 or IC2/3 DOR (n= 31, 50, 46, 96)
NA [1] 
(8.5 to NA)
NA [1] 
(NA to NA)
8.3 [2] 
(7.0 to NA)
NA [1] 
(8.3 to NA)
[1]
Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
[2]
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
6.Secondary Outcome
Title DOR as Assessed by INV Per Modified RECIST
Hide Description DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 55 143 134 277
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 DOR (n= 13, 33, 35, 68)
NA [1] 
(4.4 to NA)
NA [1] 
(8.1 to NA)
NA [1] 
(7.4 to NA)
NA [1] 
(8.1 to NA)
TC3 or IC2/3 DOR (n= 20, 54, 49, 103)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(7.4 to NA)
NA [1] 
(NA to NA)
TC2/3 or IC2/3 DOR (n = 22, 56, 50, 106)
NA [1] 
(4.5 to NA)
NA [1] 
(NA to NA)
NA [1] 
(7.4 to NA)
NA [1] 
(NA to NA)
[1]
Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
7.Secondary Outcome
Title Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1
Hide Description PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 PFS (n = 65, 122, 115, 237)
5.5
(2.7 to 8.3)
4.1
(1.8 to 5.5)
4.2
(2.8 to 5.6)
4.1
(2.8 to 5.4)
TC3 or IC2/3 PFS (n = 123, 247, 236, 483)
5.6
(3.3 to 8.3)
2.8
(1.5 to 4.0)
2.8
(2.7 to 4.0)
2.8
(2.7 to 3.0)
TC2/3 or IC2/3 PFS (n= 139, 267, 253, 520)
5.5
(3.0 to 6.9)
2.8
(1.5 to 3.5)
2.8
(2.7 to 3.7)
2.8
(2.7 to 2.9)
8.Secondary Outcome
Title PFS as Assessed by INV Per RECIST v1.1
Hide Description PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 PFS (n= 65, 122, 115, 237)
7.1 [1] 
(4.9 to NA)
4.1
(2.7 to 6.5)
4.2
(3.0 to 6.2)
4.2
(2.9 to 5.6)
TC3 or IC2/3 PFS (n= 123, 247, 236, 483)
7.6
(5.9 to 9.9)
3.0
(2.7 to 4.2)
3.5
(2.8 to 4.2)
3.2
(2.8 to 4.1)
TC2/3 or IC2/3 PFS (n= 139, 267, 253, 520)
7.1
(5.6 to 8.4)
2.8
(2.6 to 4.1)
3.0
(2.8 to 4.1)
3.0
(2.8 to 4.1)
[1]
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
9.Secondary Outcome
Title PFS as Assessed by INV Per Modified RECIST
Hide Description PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 PFS (n= 65, 122, 115, 237)
7.1 [1] 
(4.7 to NA)
5.7
(4.1 to 8.4)
6.3
(4.1 to 8.1)
5.8
(4.3 to 7.1)
TC3 or IC2/3 PFS (n= 123, 247, 236, 483)
7.9
(5.7 to 10.0)
4.5
(4.0 to 6.0)
4.9
(4.1 to 6.8)
4.6
(4.1 to 5.7)
TC2/3 or IC2/3 PFS (n= 139, 267, 253, 520)
7.6
(5.6 to 9.9)
4.2
(3.9 to 5.7)
4.6
(4.1 to 6.3)
4.4
(4.1 to 5.5)
[1]
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
10.Secondary Outcome
Title Overall Survival : Percentage of Participants Without Event (Death)
Hide Description [Not Specified]
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Unit of Measure: percentage of participants
TC3 or IC3 (n=65, 122, 115, 237) 70.8 70.5 67.0 68.8
TC3 or IC2/3 (n= 123, 247, 236, 483) 75.6 69.2 60.6 65.0
TC2/3 or IC2/3 (n= 139, 267, 253, 520) 74.1 67.4 60.5 64.0
11.Secondary Outcome
Title Overall Survival : Median Time to Event (Death)
Hide Description Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
TC3 or IC3 (n= 65, 122, 115, 237)
NA [1] 
(10.4 to NA)
NA [1] 
(10.6 to NA)
NA [1] 
(NA to NA)
NA [1] 
(12.1 to NA)
TC3 or IC2/3 (n= 123, 247, 236, 483)
14.0 [2] 
(14.0 to NA)
NA [1] 
(12.1 to NA)
NA [1] 
(8.4 to NA)
NA [1] 
(12.1 to NA)
TC2/3 or IC2/3 (n= 139, 267, 253, 520)
14.0 [2] 
(14.0 to NA)
NA [1] 
(11.2 to NA)
NA [1] 
(8.4 to NA)
NA [1] 
(11.2 to NA)
[1]
Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
[2]
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
12.Secondary Outcome
Title Percentage of Participants Without an Event (Death) at 6 Months
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237)
79.2
(69.1 to 89.3)
79.7
(72.5 to 87.0)
75.1
(67.1 to 83.1)
77.4
(72.0 to 82.8)
TC3 or IC2/3 (n= 123, 247, 236, 483)
83.9
(77.2 to 90.5)
78.1
(72.8 to 83.4)
71.0
(65.2 to 76.9)
74.6
(70.6 to 78.5)
TC2/3 or IC2/3 (n= 139, 267, 253, 520)
81.7
(75.1 to 88.4)
76.2
(71.0 to 81.5)
70.5
(64.9 to 76.2)
73.4
(69.5 to 77.3)
13.Secondary Outcome
Title Percentage of Participants Without an Event (Death) at 12 Months
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237)
58.6
(40.7 to 76.5)
61.5
(49.0 to 74.0)
62.6
(52.8 to 72.5)
61.3
(52.7 to 69.8)
TC3 or IC2/3 (n= 123, 247, 236, 483)
67.1
(55.7 to 78.4)
59.3
(50.5 to 68.1)
54.9
(47.7 to 62.2)
56.5
(50.6 to 62.5)
TC2/3 or IC2/3 (n=139, 267, 253, 520)
65.0
(54.0 to 76.1)
57.2
(48.6 to 65.7)
54.4
(47.3 to 61.5)
55.3
(49.5 to 61.1)
14.Secondary Outcome
Title PFS: Percentage of Participants Alive and Progression Free at 6 Months
Hide Description PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237)
57.4
(44.7 to 70.1)
41.3
(32.3 to 50.4)
42.1
(33.1 to 51.2)
41.8
(35.4 to 48.2)
TC3 or IC2/3 (n= 123, 247, 236, 483)
58.6
(49.5 to 67.8)
36.1
(29.9 to 42.2)
35.8
(29.6 to 41.9)
35.9
(31.6 to 40.3)
TC2/3 or IC2/3 (n= 139, 267, 253, 520)
56.4
(47.8 to 65.1)
34.8
(29.0 to 40.7)
34.7
(28.7 to 40.6)
34.8
(30.6 to 38.9)
15.Secondary Outcome
Title PFS: Percentage of Participants Alive and Progression Free at 12 Months
Hide Description PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed within the specified group.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237)
33.1
(14.9 to 51.3)
27.8
(17.6 to 37.9)
16.1
(3.8 to 28.5)
23.1
(15.4 to 30.8)
TC3 or IC2/3 (n= 123, 247, 236, 483)
29.0
(13.1 to 45.0)
22.7
(16.1 to 29.3)
15.1
(8.3 to 21.8)
19.1
(14.4 to 23.8)
TC2/3 or IC2/3 (n= 139, 267, 253, 520)
26.9
(12.1 to 41.7)
21.8
(15.5 to 28.1)
14.7
(8.1 to 21.3)
18.5
(14.0 to 23.1)
16.Secondary Outcome
Title Time in Response (TIR) as Assessed by INV Per RECIST v1.1
Hide Description TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
[1]
Median reported is the censored value, confidence interval not estimable by Brookmeyer and Crowley method due to insufficient observed events.
17.Secondary Outcome
Title TIR as Assessed by INV Per Modified RECIST
Hide Description TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by modified RECIST. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
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Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
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Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
[1]
Median reported is the censored value, confidence interval not estimable by Brookmeyer and Crowley method due to insufficient observed events.
18.Secondary Outcome
Title TIR as Assessed by IRF Per RECIST v1.1
Hide Description TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
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Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Median (95% Confidence Interval)
Unit of Measure: months
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
0.033 [1] 
(NA to NA)
[1]
Median reported is the censored value, confidence interval not estimable by Brookmeyer and Crowley method due to insufficient observed events.
19.Secondary Outcome
Title Atezolizumab Serum Concentrations
Hide Description Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.
Time Frame Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21
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Pharmacokinetic evaluable population; n = number of participants analyzed for the specified time point.
Arm/Group Title Pharmacokinetic Evaluable Population
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Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 646
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (μg/mL)
Cycle 1 Day 1 T=0 (n=646) 0.285  (4.35)
Cycle 1 Day 1 T=0.021 (n=624) 429.0  (218)
Cycle 1 Day 2 T=1 (n=47) 299.0  (65.3)
Cycle 1 Day 4 T=3 (n=44) 220.0  (48.4)
Cycle 1 Day 8 T=7 (n=38) 155.0  (35.4)
Cycle 1 Day 15 T=14 (n=36) 106.0  (32.1)
Cycle 1 Day 21 T=21 (n=596) 87.8  (41.7)
Cycle 2 Day 21 T=42 (n=518) 134.0  (57.2)
Cycle 3 Day 21 T=63 (n=467) 163.0  (70.7)
Cycle 7 Day 21 T=147 (n=275) 212.0  (88.5)
20.Secondary Outcome
Title Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status
Hide Description Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.
Time Frame Baseline, post-baseline (up to 16 months)
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Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed at the specified time point. Number of participants analyzed = number participants who were evaluable for this outcome.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 135 257 247 504
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=135,257,247,504) 7.4 3.5 6.1 4.8
Post-Baseline (n=133,253,238,491) 45.1 36.0 37.4 36.7
21.Secondary Outcome
Title Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1
Hide Description PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed at the specified time point.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237) 58.5 68.0 73.0 70.5
TC3 or IC2/3 (n= 123, 247, 236, 483) 61.8 73.7 79.2 76.4
TC2/3 or IC2/3 (n= 139, 27, 253, 520) 63.3 75.3 79.1 77.1
22.Secondary Outcome
Title Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1
Hide Description PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
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Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed at the specified time point.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237) 50.8 63.1 68.7 65.8
TC3 or IC2/3 (n= 123, 247, 236, 483) 50.4 68.8 74.6 71.6
TC2/3 or IC2/3 (n= 139, 267, 253, 520) 52.5 70.0 74.7 72.3
23.Secondary Outcome
Title Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1
Hide Description PD was defined as at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5 mm).
Time Frame Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population; n = number of participants analyzed at the specified time point.
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab Cohorts 2 + 3
Hide Arm/Group Description:
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
Overall Number of Participants Analyzed 139 267 253 520
Measure Type: Number
Unit of Measure: percentage of participants
TC3 or IC3 (n= 65, 122, 115, 237) 36.9 56.6 60.0 58.2
TC3 or IC2/3 (n= 123, 247, 236, 483) 38.2 61.5 66.1 63.8
TC2/3 or IC2/3 (n= 139, 267, 253, 520) 39.6 62.9 66.4 64.6
Time Frame Adverse events were recorded from the date of Screening until 30 days after the final follow-up visit until data cut-off on 28 May 2015 (Up to 16 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab
Hide Arm/Group Description Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
All-Cause Mortality
Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/139 (30.94%)   96/267 (35.96%)   94/253 (37.15%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/139 (0.00%)  0/267 (0.00%)  3/253 (1.19%) 
Lymphadenitis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Splenic infarction * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Thrombocytopenia * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Cardiac disorders       
Acute coronary syndrome * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Acute myocardial infarction * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Atrial fibrillation * 1  0/139 (0.00%)  0/267 (0.00%)  2/253 (0.79%) 
Atrial flutter * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Atrioventricular block complete * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Cardiac arrest * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Cardiac failure * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Cardiac tamponade * 1  1/139 (0.72%)  2/267 (0.75%)  0/253 (0.00%) 
Cardiopulmonary failure * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Coronary artery disease * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Myocardial infarction * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Tachycardia * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Congenital, familial and genetic disorders       
Tracheo-oesophageal fistula * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Endocrine disorders       
Adrenal insufficiency * 1  1/139 (0.72%)  1/267 (0.37%)  0/253 (0.00%) 
Hypothyroidism * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/139 (0.00%)  1/267 (0.37%)  2/253 (0.79%) 
Abdominal pain upper * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Ascites * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Colitis * 1  1/139 (0.72%)  1/267 (0.37%)  1/253 (0.40%) 
Constipation * 1  1/139 (0.72%)  1/267 (0.37%)  0/253 (0.00%) 
Diarrhoea * 1  2/139 (1.44%)  1/267 (0.37%)  2/253 (0.79%) 
Dysphagia * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Gastric ulcer haemorrhage * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Gastritis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Gastrooesophageal reflux disease * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Haematemesis * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Nausea * 1  1/139 (0.72%)  3/267 (1.12%)  2/253 (0.79%) 
Oesophageal perforation * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Oesophageal stenosis * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Oesophageal varices haemorrhage * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Pancreatitis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Pancreatitis acute * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Small intestinal obstruction * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Vomiting * 1  0/139 (0.00%)  4/267 (1.50%)  3/253 (1.19%) 
General disorders       
Asthenia * 1  1/139 (0.72%)  1/267 (0.37%)  2/253 (0.79%) 
Chest pain * 1  0/139 (0.00%)  2/267 (0.75%)  2/253 (0.79%) 
Chills * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Death * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Fatigue * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
General physical health deterioration * 1  0/139 (0.00%)  1/267 (0.37%)  2/253 (0.79%) 
Hyperthermia * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Influenza like illness * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Malaise * 1  0/139 (0.00%)  2/267 (0.75%)  1/253 (0.40%) 
Non-cardiac chest pain * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Pain * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Pyrexia * 1  0/139 (0.00%)  8/267 (3.00%)  7/253 (2.77%) 
Sudden death * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Hepatobiliary disorders       
Cholecystitis * 1  1/139 (0.72%)  0/267 (0.00%)  2/253 (0.79%) 
Hepatic failure * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Hepatic haemorrhage * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Hepatomegaly * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Infections and infestations       
Bacteraemia * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Bronchitis * 1  2/139 (1.44%)  1/267 (0.37%)  0/253 (0.00%) 
Bronchopneumonia * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Catheter site infection * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Clostridium difficile colitis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Empyema * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Encephalitis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Febrile infection * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Gastrointestinal infection * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Infection * 1  0/139 (0.00%)  1/267 (0.37%)  2/253 (0.79%) 
Infectious colitis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Infectious pleural effusion * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Influenza * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Lobar pneumonia * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Lower respiratory tract infection * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Lung abscess * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Lung infection * 1  1/139 (0.72%)  3/267 (1.12%)  0/253 (0.00%) 
Osteomyelitis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Peritonitis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Pneumonia * 1  3/139 (2.16%)  7/267 (2.62%)  12/253 (4.74%) 
Pneumonia bacterial * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Pyelonephritis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Sepsis * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Septic shock * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Subcutaneous abscess * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Upper respiratory tract infection * 1  1/139 (0.72%)  0/267 (0.00%)  1/253 (0.40%) 
Urinary tract infection * 1  1/139 (0.72%)  1/267 (0.37%)  2/253 (0.79%) 
Vestibular neuronitis * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Viral upper respiratory tract infection * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Injury, poisoning and procedural complications       
Allergic transfusion reaction * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Fall * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Femur fracture * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Incisional hernia * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Infusion related reaction * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Traumatic haemothorax * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Investigations       
Aspartate aminotransferase increased * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Blood lactate dehydrogenase increased * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Hepatic enzyme increased * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Dehydration * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Failure to thrive * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Hypercalcaemia * 1  0/139 (0.00%)  5/267 (1.87%)  1/253 (0.40%) 
Hyponatraemia * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  2/139 (1.44%)  1/267 (0.37%)  2/253 (0.79%) 
Bone pain * 1  0/139 (0.00%)  0/267 (0.00%)  2/253 (0.79%) 
Intervertebral disc compression * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Muscular weakness * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Musculoskeletal chest pain * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Pathological fracture * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Spinal pain * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Glioblastoma multiforme * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Lymphangiosis carcinomatosa * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Malignant pleural effusion * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Pericardial effusion malignant * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Tumour pain * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Nervous system disorders       
Cerebral haemorrhage * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Cerebral infarction * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Cerebrovascular accident * 1  0/139 (0.00%)  1/267 (0.37%)  3/253 (1.19%) 
Dysarthria * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Headache * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Ischaemic stroke * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Motor dysfunction * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Myelopathy * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Paraplegia * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Presyncope * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Somnolence * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Spinal cord compression * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Subarachnoid haemorrhage * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Transient ischaemic attack * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
VIIth nerve paralysis * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Vocal cord paralysis * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Psychiatric disorders       
Confusional state * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Disorientation * 1  0/139 (0.00%)  2/267 (0.75%)  0/253 (0.00%) 
Mental status changes * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Renal and urinary disorders       
Acute kidney injury * 1  0/139 (0.00%)  1/267 (0.37%)  2/253 (0.79%) 
Nephrolithiasis * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Renal infarct * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Reproductive system and breast disorders       
Pelvic pain * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchial haemorrhage * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Bronchial obstruction * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Chronic obstructive pulmonary disease * 1  1/139 (0.72%)  2/267 (0.75%)  2/253 (0.79%) 
Cough * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Dyspnoea * 1  3/139 (2.16%)  4/267 (1.50%)  11/253 (4.35%) 
Haemoptysis * 1  0/139 (0.00%)  2/267 (0.75%)  4/253 (1.58%) 
Hypoxia * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Interstitial lung disease * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Laryngeal haemorrhage * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Pleural effusion * 1  2/139 (1.44%)  1/267 (0.37%)  2/253 (0.79%) 
Pneumonia aspiration * 1  0/139 (0.00%)  1/267 (0.37%)  2/253 (0.79%) 
Pneumonitis * 1  2/139 (1.44%)  8/267 (3.00%)  5/253 (1.98%) 
Pneumothorax * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Pulmonary embolism * 1  2/139 (1.44%)  2/267 (0.75%)  1/253 (0.40%) 
Pulmonary haemorrhage * 1  0/139 (0.00%)  1/267 (0.37%)  1/253 (0.40%) 
Pulmonary oedema * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Respiratory distress * 1  0/139 (0.00%)  0/267 (0.00%)  2/253 (0.79%) 
Respiratory failure * 1  1/139 (0.72%)  2/267 (0.75%)  1/253 (0.40%) 
Tracheal stenosis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatomyositis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Surgical and medical procedures       
Alcohol detoxification * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  1/139 (0.72%)  1/267 (0.37%)  0/253 (0.00%) 
Embolism * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Haematoma * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Hypotension * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Internal haemorrhage * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Jugular vein thrombosis * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
Orthostatic hypotension * 1  0/139 (0.00%)  0/267 (0.00%)  1/253 (0.40%) 
Peripheral arterial occlusive disease * 1  1/139 (0.72%)  0/267 (0.00%)  0/253 (0.00%) 
Superior vena cava syndrome * 1  0/139 (0.00%)  1/267 (0.37%)  0/253 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: First Line Atezolizumab Cohort 2: Second Line Atezolizumab Cohort 3: Third Line and Beyond Atezolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   115/139 (82.73%)   219/267 (82.02%)   224/253 (88.54%) 
Blood and lymphatic system disorders       
Anaemia * 1  11/139 (7.91%)  22/267 (8.24%)  14/253 (5.53%) 
Gastrointestinal disorders       
Abdominal pain * 1  8/139 (5.76%)  15/267 (5.62%)  15/253 (5.93%) 
Constipation * 1  17/139 (12.23%)  35/267 (13.11%)  39/253 (15.42%) 
Diarrhoea * 1  23/139 (16.55%)  50/267 (18.73%)  36/253 (14.23%) 
Dry mouth * 1  8/139 (5.76%)  13/267 (4.87%)  10/253 (3.95%) 
Nausea * 1  26/139 (18.71%)  59/267 (22.10%)  53/253 (20.95%) 
Vomiting * 1  16/139 (11.51%)  34/267 (12.73%)  33/253 (13.04%) 
General disorders       
Asthenia * 1  12/139 (8.63%)  23/267 (8.61%)  33/253 (13.04%) 
Chest pain * 1  5/139 (3.60%)  13/267 (4.87%)  21/253 (8.30%) 
Chills * 1  4/139 (2.88%)  15/267 (5.62%)  14/253 (5.53%) 
Fatigue * 1  45/139 (32.37%)  74/267 (27.72%)  83/253 (32.81%) 
Influenza like illness * 1  11/139 (7.91%)  17/267 (6.37%)  13/253 (5.14%) 
Malaise * 1  8/139 (5.76%)  6/267 (2.25%)  8/253 (3.16%) 
Oedema peripheral * 1  5/139 (3.60%)  20/267 (7.49%)  18/253 (7.11%) 
Pain * 1  10/139 (7.19%)  12/267 (4.49%)  8/253 (3.16%) 
Pyrexia * 1  18/139 (12.95%)  38/267 (14.23%)  39/253 (15.42%) 
Infections and infestations       
Nasopharyngitis * 1  11/139 (7.91%)  5/267 (1.87%)  10/253 (3.95%) 
Upper respiratory tract infection * 1  9/139 (6.47%)  14/267 (5.24%)  14/253 (5.53%) 
Urinary tract infection * 1  3/139 (2.16%)  17/267 (6.37%)  9/253 (3.56%) 
Investigations       
Weight decreased * 1  6/139 (4.32%)  17/267 (6.37%)  23/253 (9.09%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  32/139 (23.02%)  47/267 (17.60%)  68/253 (26.88%) 
Hypokalaemia * 1  10/139 (7.19%)  4/267 (1.50%)  9/253 (3.56%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  14/139 (10.07%)  30/267 (11.24%)  31/253 (12.25%) 
Back pain * 1  15/139 (10.79%)  24/267 (8.99%)  27/253 (10.67%) 
Musculoskeletal chest pain * 1  9/139 (6.47%)  12/267 (4.49%)  10/253 (3.95%) 
Musculoskeletal pain * 1  6/139 (4.32%)  13/267 (4.87%)  24/253 (9.49%) 
Myalgia * 1  2/139 (1.44%)  14/267 (5.24%)  13/253 (5.14%) 
Pain in extremity * 1  11/139 (7.91%)  20/267 (7.49%)  14/253 (5.53%) 
Nervous system disorders       
Dizziness * 1  6/139 (4.32%)  16/267 (5.99%)  20/253 (7.91%) 
Headache * 1  12/139 (8.63%)  18/267 (6.74%)  28/253 (11.07%) 
Psychiatric disorders       
Anxiety * 1  4/139 (2.88%)  16/267 (5.99%)  12/253 (4.74%) 
Insomnia * 1  9/139 (6.47%)  13/267 (4.87%)  16/253 (6.32%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  33/139 (23.74%)  45/267 (16.85%)  66/253 (26.09%) 
Dyspnoea * 1  34/139 (24.46%)  38/267 (14.23%)  56/253 (22.13%) 
Haemoptysis * 1  9/139 (6.47%)  12/267 (4.49%)  9/253 (3.56%) 
Nasal congestion * 1  7/139 (5.04%)  2/267 (0.75%)  2/253 (0.79%) 
Productive cough * 1  6/139 (4.32%)  14/267 (5.24%)  9/253 (3.56%) 
Skin and subcutaneous tissue disorders       
Dry skin * 1  12/139 (8.63%)  15/267 (5.62%)  13/253 (5.14%) 
Pruritus * 1  16/139 (11.51%)  31/267 (11.61%)  29/253 (11.46%) 
Rash * 1  12/139 (8.63%)  27/267 (10.11%)  21/253 (8.30%) 
Hyperhidrosis * 1  5/139 (3.60%)  15/267 (5.62%)  5/253 (1.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02031458     History of Changes
Other Study ID Numbers: GO28754
2013-003330-32 ( EudraCT Number )
First Submitted: December 16, 2013
First Posted: January 9, 2014
Results First Submitted: October 24, 2016
Results First Posted: March 23, 2017
Last Update Posted: February 5, 2019