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

• ClinicalTrials.gov Identifier: NCT01846416
• Recruitment Status: Completed
• First Posted: May 3, 2013
• Results First Posted: December 16, 2016
• Last Update Posted: January 8, 2019
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small Cell Lung Cancer
• Intervention: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
• Enrollment: 138

Participant Flow

Recruitment Details
Pre-assignment Details	Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280): 2L+ Participants	Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
Arm/Group Description	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Period Title: Treatment Phase
Started	31	93	13
Completed	0	0	0
Not Completed	31	93	13
Reason Not Completed
Death	2	9	1
Withdrawal by Subject	2	4	2
Other	1	5	1
Physician Decision	1	2	0
Adverse Event	3	4	0
Non-compliance	0	2	0
Study Terminated by Sponsor	1	4	0
Progressive Disease	21	63	9
Period Title: Survival Follow-up
Started	28	80	12
Completed	0	0	0
Not Completed	28	80	12
Reason Not Completed
Death	21	62	9
Lost to Follow-up	0	2	2
Withdrawal by Subject	2	7	0
Study Terminated by Sponsor	2	8	0
Other	3	1	1

Baseline Characteristics

Arm/Group Title		Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants	Total
Arm/Group Description		Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Total of all reporting groups
Overall Number of Baseline Participants		31	93	13	137
Baseline Analysis Population Description		All participants who received any dose of atezolizumab during the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	31 participants	93 participants	13 participants	137 participants
		68 (10.8)	65.2 (9.3)	63.8 (7.7)	65.7 (9.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	31 participants	93 participants	13 participants	137 participants
	Female	17 54.8%	34 36.6%	7 53.8%	58 42.3%
	Male	14 45.2%	59 63.4%	6 46.2%	79 57.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Description	Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
Time Frame	Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	32; (17 to 51)	21; (13 to 30)	23; (5 to 54)

2. Secondary Outcome

Title	Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
Description	Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.
Time Frame	Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	29; (14 to 48)	19; (11 to 28)	23; (5 to 54)

3. Secondary Outcome

Title	Duration of Objective Response According to RECIST v1.1
Description	Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.
Time Frame	Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population with a confirmed objective response.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	9	17	3
Median (Full Range); Unit of Measure: months
	9.2; (2.3 to 30.4)	17.0; (2.8 to 44.2)	NA [1]; (2.8 to 9.9)

[1]

Median DOR was not reached.

4. Secondary Outcome

Title	Percentage of Participants With 6-Month Duration of Objective Response
Description	Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population with a confirmed objective response.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	8	15	3
Measure Type: Number; Unit of Measure: percentage of participants
	75.0	91.7	66.7

5. Secondary Outcome

Title	Percentage of Participants With Disease Progression or Death According to RECIST v1.1
Description	For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame	Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Unit of Measure: percentage of participants
	67.7	74.2	84.6

6. Secondary Outcome

Title	Progression-Free Survival (PFS) According to RECIST v1.1
Description	PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.
Time Frame	Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Median (Full Range); Unit of Measure: months
	4.5; (0.9 to 37.9)	2.7; (0.0 to 45.5)	2.5; (1.0 to 11.3)

7. Secondary Outcome

Title	Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Description	Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame	Months 6, 12 and 30

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Unit of Measure: percentage of participants
Month 6	33.50	32.29	15.38
Month 12	20	23	NA [1]
Month 30	13	10	NA [1]

[1]

Not estimable

8. Secondary Outcome

Title	Percentage of Participants With Disease Progression or Death According to Modified RECIST
Description	For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Time Frame	Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Unit of Measure: percentage of participants
	58.1	66.7	69.2

9. Secondary Outcome

Title	PFS According to Modified RECIST
Description	PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.
Time Frame	Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Median (Full Range); Unit of Measure: months
	5.5; (0.9 to 37.9)	3.7; (0.0 to 45.5)	4.3; (1.1 to 16.2)

10. Secondary Outcome

Title	Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Description	Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Time Frame	Months 6, 12 and 30

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Unit of Measure: percentage of participants
Month 6	43.12	39.10	44.87
Month 12	31	29	24
Month 30	12	10	NA [1]

[1]

Not estimable

11. Secondary Outcome

Title	Percentage of Participants With Death
Description	Participants were followed for survival throughout the study.
Time Frame	Baseline till death or up to 20 months, whichever occurred first

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Measure Type: Number; Unit of Measure: percentage of participants
	74.2	76.3	76.9

12. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.
Time Frame	Baseline till death or up to 20 months, whichever occurred first

Outcome Measure Data

Analysis Population Description

Efficacy-evaluable population.

Arm/Group Title	Atezolizumab (MPDL3280) : 1L Participants	Atezolizumab (MPDL3280) : 2L+ Participants	Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Arm/Group Description:	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed	31	93	13
Median (95% Confidence Interval); Unit of Measure: months
	14.4; (12.8 to 22.1)	9.3; (5.8 to 17.6)	6.8; (3.2 to 19.5)

13. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) for Atezolizumab
Description	[Not Specified]
Time Frame	Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points. Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.

Arm/Group Title	Atezolizumab (MPDL3280) : All Arms
Arm/Group Description:	All participants included in the study were reported.
Overall Number of Participants Analyzed	135
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: micrograms per milliliter (mcg/mL)
	405; (31.7%)

14. Secondary Outcome

Title	Minimum Plasma Concentration (Cmin) for Atezolizumab
Description	[Not Specified]
Time Frame	Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16

Outcome Measure Data

Analysis Population Description

Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.

Arm/Group Title	Atezolizumab (MPDL3280) : All Arms
Arm/Group Description:	All participants included in the study were reported.
Overall Number of Participants Analyzed	125
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
Pre-dose Cycle 2 (Day 1) (n= 125)	68.8; (55.3%)
Pre-dose Cycle 3 (Day 1) (n= 100)	90.6; (136.6%)
Pre-dose Cycle 4 (Day 1) (n= 92)	123; (136.9%)
Pre-dose Cycle 8 (Day 1) (n= 51)	206; (45.9%)
Pre-dose Cycle 16 (Day 1) (n= 1)	135 [1]; (NA%)

[1]

Geometric co-efficient of variation was not calculated as only 1 participant was analyzed at the specified time point.

Adverse Events

Time Frame	Baseline until 20 months.
Adverse Event Reporting Description	All participants who received at least one dose of atezolizumab were included in analysis.
Arm/Group Title	Atezolizumab (MPDL3280A) : 1L Participants	Atezolizumab (MPDL3280A) : 2L+ Participants	Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Arm/Group Description	Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.	Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.	Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
All-Cause Mortality
	Atezolizumab (MPDL3280A) : 1L Participants	Atezolizumab (MPDL3280A) : 2L+ Participants	Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Atezolizumab (MPDL3280A) : 1L Participants	Atezolizumab (MPDL3280A) : 2L+ Participants	Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	17/31 (54.84%)	46/93 (49.46%)	6/13 (46.15%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Febrile neutropenia * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Cardiac disorders
Cardiac tamponade * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Pericardial effusion * 1	1/31 (3.23%)	2/93 (2.15%)	0/13 (0.00%)
Atrial flutter * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Cardiac arrest * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Coronary artery disease * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Myocardial infarction * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Pericarditis constrictive * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
CARDIAC FAILURE CONGESTIVE * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
PALPITATIONS * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Endocrine disorders
Hypothyroidism * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Thyroiditis acute * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Eye disorders
Amaurosis fugax * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Photopsia * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Gastrointestinal disorders
Diarrhoea * 1	2/31 (6.45%)	1/93 (1.08%)	0/13 (0.00%)
Abdominal pain * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Abdominal wall haematoma * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Constipation * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Lower gastrointestinal haemorrhage * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Nausea * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Rectal haemorrhage * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Vomiting * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
AUTOIMMUNE COLITIS * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
COLITIS * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
General disorders
Chest pain * 1	0/31 (0.00%)	2/93 (2.15%)	2/13 (15.38%)
Pain * 1	0/31 (0.00%)	2/93 (2.15%)	0/13 (0.00%)
Pyrexia * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Infections and infestations
Pneumonia * 1	3/31 (9.68%)	8/93 (8.60%)	0/13 (0.00%)
Lower respiratory tract infection * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Upper respiratory tract infection * 1	2/31 (6.45%)	0/93 (0.00%)	0/13 (0.00%)
Abscess neck * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Bronchitis * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Groin abscess * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Herpes zoster disseminated * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Influenza * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Sepsis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Sinusitis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Injury, poisoning and procedural complications
Fall * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Hip fracture * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Spinal compression fracture * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Investigations
Alanine aminotransferase increased * 1	1/31 (3.23%)	1/93 (1.08%)	0/13 (0.00%)
Aspartate aminotransferase increased * 1	1/31 (3.23%)	1/93 (1.08%)	0/13 (0.00%)
INFLUENZA B VIRUS TEST POSITIVE * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Diabetes mellitus * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Hypocalcaemia * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
HYPERKALAEMIA * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
HYPONATRAEMIA * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain * 1	2/31 (6.45%)	3/93 (3.23%)	0/13 (0.00%)
Muscular weakness * 1	1/31 (3.23%)	1/93 (1.08%)	0/13 (0.00%)
Arthralgia * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Bone pain * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Musculoskeletal pain * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
PAIN IN EXTREMITY * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Nervous system disorders
Guillain-Barre Syndrome * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Intracranial venous sinus thrombosis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Monoparesis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Nervous system disorder * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Seizure * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Syncope * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Vocal cord paralysis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Psychiatric disorders
Confusional state * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Mental status changes * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Renal and urinary disorders
Renal failure * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	1/31 (3.23%)	6/93 (6.45%)	0/13 (0.00%)
Haemoptysis * 1	3/31 (9.68%)	2/93 (2.15%)	0/13 (0.00%)
Pleural effusion * 1	1/31 (3.23%)	1/93 (1.08%)	0/13 (0.00%)
Pulmonary embolism * 1	0/31 (0.00%)	2/93 (2.15%)	0/13 (0.00%)
Pulmonary haemorrhage * 1	0/31 (0.00%)	2/93 (2.15%)	0/13 (0.00%)
Bronchial obstruction * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Bronchostenosis * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Pneumonitis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Pulmonary hypertension * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Pulmonary oedema * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Respiratory disorder * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Vascular disorders
Deep vein thrombosis * 1	1/31 (3.23%)	0/93 (0.00%)	0/13 (0.00%)
Embolism * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Hypertension * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
Jugular vein thrombosis * 1	0/31 (0.00%)	1/93 (1.08%)	0/13 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (20.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Atezolizumab (MPDL3280A) : 1L Participants	Atezolizumab (MPDL3280A) : 2L+ Participants	Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	31/31 (100.00%)	88/93 (94.62%)	13/13 (100.00%)
Blood and lymphatic system disorders
Anaemia * 1	6/31 (19.35%)	19/93 (20.43%)	1/13 (7.69%)
Neutropenia * 1	2/31 (6.45%)	2/93 (2.15%)	0/13 (0.00%)
Thrombocytopenia * 1	1/31 (3.23%)	0/93 (0.00%)	1/13 (7.69%)
Lymphadenopathy * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Cardiac disorders
Tachycardia * 1	0/31 (0.00%)	3/93 (3.23%)	1/13 (7.69%)
Atrial fibrillation * 1	2/31 (6.45%)	2/93 (2.15%)	0/13 (0.00%)
Pericardial effusion * 1	0/31 (0.00%)	2/93 (2.15%)	1/13 (7.69%)
Aortic valve thickening * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Ear and labyrinth disorders
Vertigo * 1	1/31 (3.23%)	1/93 (1.08%)	1/13 (7.69%)
EXCESSIVE CERUMEN PRODUCTION * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Deafness bilateral * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Ear pain * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Vestibular disorder * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Endocrine disorders
Hypothyroidism * 1	1/31 (3.23%)	3/93 (3.23%)	1/13 (7.69%)
Eye disorders
Diplopia * 1	0/31 (0.00%)	2/93 (2.15%)	1/13 (7.69%)
Lacrimation increased * 1	0/31 (0.00%)	2/93 (2.15%)	1/13 (7.69%)
Vision blurred * 1	2/31 (6.45%)	1/93 (1.08%)	1/13 (7.69%)
Periorbital oedema * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
CONJUNCTIVAL HYPERAEMIA * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
Gastrointestinal disorders
Nausea * 1	11/31 (35.48%)	27/93 (29.03%)	4/13 (30.77%)
Constipation * 1	8/31 (25.81%)	16/93 (17.20%)	6/13 (46.15%)
Diarrhoea * 1	8/31 (25.81%)	17/93 (18.28%)	4/13 (30.77%)
Vomiting * 1	4/31 (12.90%)	14/93 (15.05%)	3/13 (23.08%)
Dysphagia * 1	2/31 (6.45%)	8/93 (8.60%)	1/13 (7.69%)
Gastrooesophageal reflux disease * 1	2/31 (6.45%)	7/93 (7.53%)	0/13 (0.00%)
Abdominal pain * 1	1/31 (3.23%)	7/93 (7.53%)	0/13 (0.00%)
Dyspepsia * 1	0/31 (0.00%)	3/93 (3.23%)	1/13 (7.69%)
Abdominal pain upper * 1	2/31 (6.45%)	5/93 (5.38%)	1/13 (7.69%)
Mouth swelling * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
ABDOMINAL PAIN LOWER * 1	0/31 (0.00%)	3/93 (3.23%)	1/13 (7.69%)
STOMATITIS * 1	2/31 (6.45%)	3/93 (3.23%)	0/13 (0.00%)
General disorders
Fatigue * 1	16/31 (51.61%)	38/93 (40.86%)	5/13 (38.46%)
Pyrexia * 1	7/31 (22.58%)	21/93 (22.58%)	1/13 (7.69%)
Oedema peripheral * 1	3/31 (9.68%)	14/93 (15.05%)	2/13 (15.38%)
Chest pain * 1	1/31 (3.23%)	9/93 (9.68%)	0/13 (0.00%)
Pain * 1	3/31 (9.68%)	2/93 (2.15%)	2/13 (15.38%)
Asthenia * 1	1/31 (3.23%)	9/93 (9.68%)	0/13 (0.00%)
Chills * 1	1/31 (3.23%)	5/93 (5.38%)	1/13 (7.69%)
Influenza like illness * 1	3/31 (9.68%)	4/93 (4.30%)	1/13 (7.69%)
Malaise * 1	0/31 (0.00%)	6/93 (6.45%)	0/13 (0.00%)
Gait disturbance * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
General physical health deterioration * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Immune system disorders
Drug hypersensitivity * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Infections and infestations
Upper respiratory tract infection * 1	2/31 (6.45%)	17/93 (18.28%)	0/13 (0.00%)
Pneumonia * 1	1/31 (3.23%)	8/93 (8.60%)	0/13 (0.00%)
Urinary tract infection * 1	7/31 (22.58%)	3/93 (3.23%)	2/13 (15.38%)
Candida infection * 1	2/31 (6.45%)	1/93 (1.08%)	0/13 (0.00%)
Cystitis * 1	2/31 (6.45%)	0/93 (0.00%)	0/13 (0.00%)
Fungal skin infection * 1	1/31 (3.23%)	1/93 (1.08%)	1/13 (7.69%)
Influenza * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Respiratory tract infection * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
SINUSITIS * 1	2/31 (6.45%)	2/93 (2.15%)	0/13 (0.00%)
Injury, poisoning and procedural complications
FALL * 1	1/31 (3.23%)	6/93 (6.45%)	0/13 (0.00%)
JAW FRACTURE * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
LACERATION * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
LIMB INJURY * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Investigations
Weight decreased * 1	6/31 (19.35%)	9/93 (9.68%)	1/13 (7.69%)
Alanine aminotransferase increased * 1	2/31 (6.45%)	2/93 (2.15%)	2/13 (15.38%)
Aspartate aminotransferase increased * 1	2/31 (6.45%)	3/93 (3.23%)	2/13 (15.38%)
LYMPHOCYTE COUNT DECREASED * 1	2/31 (6.45%)	3/93 (3.23%)	0/13 (0.00%)
Blood alkaline phosphatase increased * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
Haemoglobin decreased * 1	1/31 (3.23%)	0/93 (0.00%)	1/13 (7.69%)
Blood thyroid stimulating hormone increased * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Metabolism and nutrition disorders
Decreased appetite * 1	6/31 (19.35%)	22/93 (23.66%)	2/13 (15.38%)
Hypokalaemia * 1	2/31 (6.45%)	12/93 (12.90%)	4/13 (30.77%)
Hyponatraemia * 1	3/31 (9.68%)	12/93 (12.90%)	0/13 (0.00%)
Dehydration * 1	2/31 (6.45%)	7/93 (7.53%)	1/13 (7.69%)
Hypomagnesaemia * 1	0/31 (0.00%)	8/93 (8.60%)	0/13 (0.00%)
Hypercalcaemia * 1	2/31 (6.45%)	6/93 (6.45%)	0/13 (0.00%)
Hypoalbuminaemia * 1	1/31 (3.23%)	6/93 (6.45%)	0/13 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	6/31 (19.35%)	18/93 (19.35%)	2/13 (15.38%)
Back pain * 1	4/31 (12.90%)	19/93 (20.43%)	2/13 (15.38%)
Pain in extremity * 1	2/31 (6.45%)	8/93 (8.60%)	1/13 (7.69%)
Musculoskeletal pain * 1	4/31 (12.90%)	9/93 (9.68%)	1/13 (7.69%)
Musculoskeletal chest pain * 1	1/31 (3.23%)	8/93 (8.60%)	0/13 (0.00%)
Myalgia * 1	3/31 (9.68%)	5/93 (5.38%)	1/13 (7.69%)
Neck pain * 1	1/31 (3.23%)	5/93 (5.38%)	0/13 (0.00%)
Bone pain * 1	0/31 (0.00%)	3/93 (3.23%)	1/13 (7.69%)
Muscle spasms * 1	0/31 (0.00%)	4/93 (4.30%)	1/13 (7.69%)
FLANK PAIN * 1	0/31 (0.00%)	5/93 (5.38%)	0/13 (0.00%)
MUSCULAR WEAKNESS * 1	2/31 (6.45%)	4/93 (4.30%)	0/13 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain * 1	0/31 (0.00%)	4/93 (4.30%)	2/13 (15.38%)
Nervous system disorders
Headache * 1	5/31 (16.13%)	10/93 (10.75%)	3/13 (23.08%)
Dizziness * 1	4/31 (12.90%)	8/93 (8.60%)	1/13 (7.69%)
Dysgeusia * 1	4/31 (12.90%)	4/93 (4.30%)	0/13 (0.00%)
Peripheral sensory neuropathy * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
Cognitive disorder * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Hemiparesis * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
Memory impairment * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
Nystagmus * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Syncope * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
PARAESTHESIA * 1	2/31 (6.45%)	4/93 (4.30%)	0/13 (0.00%)
Psychiatric disorders
Insomnia * 1	4/31 (12.90%)	11/93 (11.83%)	1/13 (7.69%)
Anxiety * 1	0/31 (0.00%)	11/93 (11.83%)	2/13 (15.38%)
Depression * 1	3/31 (9.68%)	9/93 (9.68%)	1/13 (7.69%)
Confusional state * 1	1/31 (3.23%)	4/93 (4.30%)	1/13 (7.69%)
Hallucination * 1	0/31 (0.00%)	2/93 (2.15%)	1/13 (7.69%)
Reproductive system and breast disorders
Breast swelling * 1	1/31 (3.23%)	0/93 (0.00%)	1/13 (7.69%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	5/31 (16.13%)	33/93 (35.48%)	3/13 (23.08%)
Dyspnoea * 1	8/31 (25.81%)	30/93 (32.26%)	3/13 (23.08%)
Productive cough * 1	2/31 (6.45%)	13/93 (13.98%)	0/13 (0.00%)
Wheezing * 1	3/31 (9.68%)	7/93 (7.53%)	2/13 (15.38%)
Dysphonia * 1	1/31 (3.23%)	6/93 (6.45%)	1/13 (7.69%)
Haemoptysis * 1	3/31 (9.68%)	6/93 (6.45%)	1/13 (7.69%)
Nasal congestion * 1	1/31 (3.23%)	6/93 (6.45%)	0/13 (0.00%)
Pleural effusion * 1	2/31 (6.45%)	5/93 (5.38%)	2/13 (15.38%)
Pulmonary embolism * 1	1/31 (3.23%)	5/93 (5.38%)	0/13 (0.00%)
Dyspnoea exertional * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE * 1	2/31 (6.45%)	0/93 (0.00%)	0/13 (0.00%)
OROPHARYNGEAL PAIN * 1	2/31 (6.45%)	5/93 (5.38%)	0/13 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus * 1	5/31 (16.13%)	9/93 (9.68%)	1/13 (7.69%)
Dry skin * 1	1/31 (3.23%)	12/93 (12.90%)	0/13 (0.00%)
Night sweats * 1	2/31 (6.45%)	7/93 (7.53%)	1/13 (7.69%)
Rash * 1	3/31 (9.68%)	9/93 (9.68%)	1/13 (7.69%)
Decubitus ulcer * 1	2/31 (6.45%)	0/93 (0.00%)	0/13 (0.00%)
Acne * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
Dermatitis * 1	0/31 (0.00%)	1/93 (1.08%)	1/13 (7.69%)
RASH MACULO-PAPULAR * 1	2/31 (6.45%)	3/93 (3.23%)	0/13 (0.00%)
Vascular disorders
Hypotension * 1	3/31 (9.68%)	9/93 (9.68%)	0/13 (0.00%)
Hypertension * 1	3/31 (9.68%)	3/93 (3.23%)	1/13 (7.69%)
Hot flush * 1	0/31 (0.00%)	2/93 (2.15%)	1/13 (7.69%)
Haematoma * 1	0/31 (0.00%)	0/93 (0.00%)	1/13 (7.69%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (20.1)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

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

Results Point of Contact

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

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

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

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01846416
• Other Study ID Numbers: GO28625; 2013-000177-69 ( EudraCT Number )
• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Results First Submitted: October 24, 2016
• Results First Posted: December 16, 2016
• Last Update Posted: January 8, 2019