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

Non-Small Cell Lung Cancer Clinical Trial

— BIRCH  

Official title:

A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031458
• Other study ID #: GO28754
• Secondary ID: 2013-003330-32
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2014
• Est. completion date: January 11, 2019

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: January 11, 2019
• Est. primary completion date: May 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants greater than or equal to 18 years of age

• Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

• PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory

• Measurable disease, as defined by RECIST version 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

• Central nervous system (CNS) disease, including treated brain metastases

• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome

• History of autoimmune disease

• History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted

• Active hepatitis B or hepatitis C

• Human Immunodeficiency virus (HIV) positive

• Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Atezolizumab
1200 mg IV every 3 weeks

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria
Australia	Peter Maccallum Cancer Institute; Medical Oncology	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital; Medical Oncology	Nedlands	Western Australia
Australia	Royal North Shore Hospital; Oncology	St. Leonards	New South Wales
Australia	Princess AleXandra Hospital; Department of Medical Oncology	Woolloongabba	Queensland
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	GHdC Site Saint-Joseph	Charleroi
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	Sint Augustinus Wilrijk	Wilrijk
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	University Clinical Center Sarajevo;Clinic for Pulmonary disease	Sarajevo
Bosnia and Herzegovina	University Clinical Center Sarajevo;Institute of oncology	Sarajevo
Bulgaria	Complex Oncology Center (COC)-Plovidiv	Plovdiv
Bulgaria	Specialized Hospital for Active Treatment of Oncology	Sofia
Canada	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario
Canada	The Ottawa Hospital Cancer Centre; Oncology	Ottawa	Ontario
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
France	Hopital Augustin Morvan; Oncologie Thoracique	Brest
France	Hopital Cote De Nacre; Pneumologie	Caen
France	CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee	Limoges
France	Centre Leon Berard; Departement Oncologie Medicale	Lyon
France	Hopital Arnaud De Villeneuve; Maladies Respiratoires	Montpellier
France	Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale	Nantes
France	Nouvel Hopital Civil; Pneumologie	Strasbourg
France	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif
Georgia	Cancer Research Centre	Tbilisi
Georgia	Chemotherapy and Immunotherapy Clinic Medulla	Tbilisi
Georgia	MediClab Georgia	Tbilisi
Georgia	Research institute for Clinical Medicine	Tbilisi
Germany	Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung	Essen
Germany	LungenClinic Großhansdorf GmbH	Großhansdorf
Germany	Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin	Nürnberg
Germany	Pius-Hospital; Klinik fuer Haematologie und Onkologie	Oldenburg
Germany	Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie	Villingen-Schwenningen
Hong Kong	Queen Elizabeth Hospital; Clinical Oncology	Hong Kong
Hong Kong	Queen Mary Hospital; Dept. of Clinical Oncology	Hong Kong
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico	Orbassano	Piemonte
Japan	National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine	Fukuoka
Japan	Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine	Kanagawa
Japan	Kitasato University Hospital; Respiratory Medicine	Kanagawa
Japan	Yokohama Municipal Citizen'S Hospital; Respiratory Medicine	Kanagawa
Japan	Kyoto University Hospital, Respiratory Medicine	Kyoto
Japan	Sendai Kousei Hospital; Pulmonary Medicine	Miyagi
Japan	Kansai Medical university Hospital; Thoracic Oncology	Osaka
Japan	Osaka Habikino Medical Center	Osaka
Japan	Osaka International Cancer Institute; Thoracic Oncology	Osaka
Japan	National Cancer Center Hospital; Thoracic Medical Oncology	Tokyo
Japan	Toranomon Hospital; Respiratory Medicine	Tokyo
Netherlands	Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology	Amsterdam
Netherlands	Amphia Ziekenhuis; Afdeling Longziekten	Breda
Netherlands	Academ Ziekenhuis Groningen; Medical Oncology	Groningen
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	ICO Badalona - Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Switzerland	Universitaetsspital Basel; Onkologie	Basel
Switzerland	CHUV; Departement d'Oncologie	Lausanne
Switzerland	Kantonsspital St. Gallen; Onkologie/Hämatologie	St. Gallen
Switzerland	UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie	Zürich
Turkey	Ankara Ataturk Chest Diseases Training and Research Hospital	Ankara
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Ankara
Turkey	Ege University School of Medicine; Chest Diseases Department	Izmir
Turkey	Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department	Malatya
United Kingdom	Barts & London School of Med; Medical Oncology	London
United Kingdom	Royal Marsden Hospital - London	London
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton
United States	Emory Uni - Winship Cancer Center; Hematology/Oncology	Atlanta	Georgia
United States	University of Colorado Health Science Center; Biomedical Research Bldg. Room 511	Aurora	Colorado
United States	Uni of Maryland; Greenebaum Cancer Center	Baltimore	Maryland
United States	Beth Israel Deaconess Med Ctr; Hem/Onc	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia; Office of Sponsored Programs	Charlottesville	Virginia
United States	Northwestern University; Robert H. Lurie Comp Can Ctr	Chicago	Illinois
United States	University Of Chicago Medical Center; Section Of Hematology/Oncology	Chicago	Illinois
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University; B406 Starling-Loving Hall	Columbus	Ohio
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Florida Cancer Specialists; SCRI	Fort Myers	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	Carolina BioOncology Institute, PLCC	Huntersville	North Carolina
United States	Monter Cancer Center	Lake Success	New York
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Angeles Clinic & Rsch Inst	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Northwest Georgia Oncology Centers PC - Marietta	Marietta	Georgia
United States	Tennessee Oncology PLLC - Nashville (20th Ave)	Nashville	Tennessee
United States	Yale Cancer Center; Medical Oncology	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Florida Hospital Cancer Inst	Orlando	Florida
United States	Fox Chase Cancer Center; Hematology/Oncology	Philadelphia	Pennsylvania
United States	Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Florida Cancer Specialists.	Saint Petersburg	Florida
United States	Huntsman Cancer Institute; University of Utah	Salt Lake City	Utah
United States	HonorHealth Research Institute - Bisgrove	Scottsdale	Arizona
United States	University of Washington Seattle Cancer Care Alliance	Seattle	Washington
United States	City of Hope National Medical Group	South Pasadena	California
United States	Stanford Cancer Center	Stanford	California
United States	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  France,  Georgia,  Germany,  Hong Kong,  Italy,  Japan,  Netherlands,  Singapore,  Slovenia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).	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)
Secondary	Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)	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).	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)
Secondary	Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV	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).	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)
Secondary	Duration of Response (DOR) Assessed by IRF Per RECIST v1.1	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).	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)
Secondary	DOR as Assessed by INV Per RECIST v1.1	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).	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)
Secondary	DOR as Assessed by INV Per Modified RECIST	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).	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)
Secondary	Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1	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.	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)
Secondary	PFS as Assessed by INV Per RECIST v1.1	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.	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)
Secondary	PFS as Assessed by INV Per Modified RECIST	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.	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)
Secondary	Overall Survival : Percentage of Participants Without Event (Death)		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)
Secondary	Overall Survival : Median Time to Event (Death)	Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.	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)
Secondary	Percentage of Participants Without an Event (Death) at 6 Months		Month 6
Secondary	Percentage of Participants Without an Event (Death) at 12 Months		Month 12
Secondary	PFS: Percentage of Participants Alive and Progression Free at 6 Months	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.	Month 6
Secondary	PFS: Percentage of Participants Alive and Progression Free at 12 Months	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.	Month 12
Secondary	Time in Response (TIR) as Assessed by INV Per RECIST v1.1	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.	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)
Secondary	TIR as Assessed by INV Per Modified RECIST	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.	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)
Secondary	TIR as Assessed by IRF Per RECIST v1.1	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.	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)
Secondary	Atezolizumab Serum Concentrations	Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.	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
Secondary	Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status	Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.	Baseline, post-baseline (up to 16 months)
Secondary	Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1	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.	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)
Secondary	Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1	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.	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)
Secondary	Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1	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).	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)