A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

— OAK  

Official title:

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008227
• Other study ID #: GO28915
• Secondary ID: 2013-003331-30
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2014
• Est. completion date: January 9, 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 global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: January 9, 2019
• Est. primary completion date: July 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

• Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent

• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

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

Exclusion Criteria:

• Known active or untreated central nervous system (CNS) metastases

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

• History of autoimmune disease

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

• Active hepatitis B or hepatitis C

• Prior treatment with docetaxel

• Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (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-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Atezolizumab
1200 mg IV infusion on Day 1 of each 21-day cycle
• Docetaxel
75 mg/m^2 IV infusion on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
Argentina	Instituto Medico Rio Cuarto	Córdoba
Argentina	COIBA	Provincia De Buenos Aires
Argentina	Instituto de Oncología de Rosario	Rosario
Austria	Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin	Innsbruck
Austria	Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.	Salzburg
Austria	Lkh Vöcklabruck; I. Abt. Für Innere Medizin	Vöcklabruck
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Cite de La Sante de Laval; Hemato-Oncologie	Laval	Quebec
Canada	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Chile	Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas	Recoleta
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Chile	ONCOCENTRO APYS; Oncología	Vina Del Mar
Finland	Helsinki University Central Hospital; Dep. of Pulmonary Medicine	Helsinki
Finland	Oulu University Hospital; Oncology	Oulu
Finland	Tampere University Hospital; Dept of Oncology	Tampere
France	Institut Sainte Catherine	Avignon
France	Hopital Jean Minjoz; Pneumologie	Besancon
France	Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie	Bordeaux
France	Centre Francois Baclesse	Caen
France	Centre Hospitalier Intercommunal; Service de Pneumologie	Creteil
France	Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie	Grenoble
France	Centre Jean Bernard; Radiotherapie Chimiotherapie	Le Mans
France	Centre Oscar Lambret	Lille
France	Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique	Marseille
France	Hopital Emile Muller;Pneumologie	Mulhouse
France	GH Paris Saint Joseph; Pneumologie	Paris
France	Hopital Cochin; Unite Fonctionnelle D Oncologie	Paris
France	Hopital Saint Louis; Oncologie Medicale	Paris
France	Hopital Tenon;Pneumologie	Paris
France	Centre Hospitalier Lyon Sud; Pneumologie	Pierre Benite
France	CH de la region d Annecy	Pringy
France	Hopital de Pontchaillou; Service de Pneumologie	Rennes
France	Centre Paul Strauss; Oncologie Medicale	Strasbourg
France	Hopital Foch; Pneumologie	Suresnes
France	Hia Sainte Anne; Pneumologie	Toulon
France	Hopital Larrey; Pneumologie	Toulouse
Germany	Helios Klinikum Emil von Behring GmbH	Berlin
Germany	Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie	Frankfurt
Germany	Asklepios-Fachkliniken Muenchen-Gauting; Onkologie	Gauting
Germany	Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II	Halle
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Fachklinik für Lungenerkrankungen	Immenhausen
Germany	Krankenhaus Merheim Lungenklinik	Köln
Germany	Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie	Regensburg
Greece	Uoa Sotiria Hospital; Oncology	Athens
Greece	University Hospital of Patras Medical Oncology	Patras
Greece	Thermi Clinic; Oncology Clinic	Thermi Thessalonikis
Guatemala	Grupo Angeles	Guatemala City
Hungary	Semmelweis Egyetem X; Pulmonologiai Klinika	Budapest
Hungary	University of Pecs, I st Dept of Internal Medicine	Pecs
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Italy	Azienda Ospedaliera San Giuseppe Moscati	Avellino	Campania
Italy	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia
Italy	Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica	Bari	Puglia
Italy	POLICLINICO RODOLICO, U.O. di Oncologia Medica	Catania	Sicilia
Italy	Istituto Nazionale per la Ricerca sul Cancro di Genova	Genova	Liguria
Italy	Ospedale San Luca; Oncologia	Lucca	Toscana
Italy	Irccs Ospedale San Raffaele;Oncologia Medica	Milano	Lombardia
Italy	Istituto Europeo Di Oncologia	Milano	Lombardia
Italy	ASST DI MONZA; Oncologia Medica	Monza	Lombardia
Italy	Seconda Universita' Degli Studi; Divsione Di Oncologia Medica	Napoli	Campania
Italy	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda	Padova	Veneto
Italy	Azienda Ospedaliera Univ Parma; Dept Oncologia Medica	Parma	Emilia-Romagna
Italy	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana
Italy	Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna	Roma	Lazio
Italy	Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato	Udine	Friuli-Venezia Giulia
Italy	A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina	Verona	Veneto
Japan	Aichi Cancer Center Hospital; Respiratory Medicine	Aichi
Japan	National Cancer Center Hospital East; Thoracic Oncology	Chiba
Japan	National Hospital Organization Shikoku Cancer Center; Internal Medicine	Ehime
Japan	National Hospital Organization Kyushu Cancer Center, Thoracic Oncology	Fukuoka
Japan	Hyogo Cancer Center; Thoracic Oncology	Hyogo
Japan	Kobe City Medical Center General Hospital; Respiratory Medicine	Hyogo
Japan	Miyagi Cancer Center; Respiratory Medicine	Miyagi
Japan	Okayama University Hospital; Respiratory and Allergy Medicine	Okayama
Japan	Kindai University Hospital; Medical Oncology	Osaka
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine	Osaka
Japan	Saitama Cancer Center; Thoracic Oncology	Saitama
Japan	Shizuoka Cancer Center; Thoracic Oncology	Shizuoka
Japan	National Cancer Center Hospital; Thoracic Medical Oncology	Tokyo
Japan	The Cancer Institute Hospital of JFCR, Respiratory Medicine	Tokyo
Japan	Tokyo Medical University Hospital; Dept of Surgery	Tokyo
Japan	National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine	Yamaguchi
Korea, Republic of	National Cancer Center; Medical Oncology	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital; Hematology Medical Oncology	Gyeonggi-do
Korea, Republic of	Samsung Medical Center; Gastroenterology	Seoul
Korea, Republic of	Seoul National Uni Hospital; Internal Medicine	Seoul
Korea, Republic of	Seoul St.Mary's Hospital; Medical Oncology	Seoul
Korea, Republic of	Yonsei University Severance Hospital; Medical Oncology	Seoul
Netherlands	Jeroen Bosch Ziekenhuis	'S Hertogenbosch
Netherlands	Catharina Ziekenhuis; Dept of Lung Diseases	Eindhoven
Netherlands	Antonius Ziekenhuis; Dept of Lung Diseases	Nieuwegein
New Zealand	Auckland city hospital; Auckland Regional Cancer Centre and Blood Service	Auckland
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital; Dept of Medical Oncology	Hamilton
Norway	Oslo Universitetssykehus HF; Radiumhospitalet	Oslo
Panama	Centro Hemato Oncologico Panama	Panama
Poland	Medical University of Gdansk	Gdansk
Poland	Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii	Lodz
Poland	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii	Otwock
Poland	Med.-Polonia Sp. z o.o. NSZOZ	Poznan
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii	Warszawa
Portugal	Hospital Geral; Servico de Pneumologia	Coimbra
Portugal	Hospital Pulido Valente; Servico de Pneumologia	Lisboa
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Russian Federation	N.N.Burdenko Main Military Clinical Hospital; Oncology Dept	Moscow
Russian Federation	City Clinical Onc.	Saint-Petersburg
Russian Federation	SBI of Healthcare Samara Regional Clinical Oncology Dispensary	Samara
Serbia	Clinic for Pulmonology, Clinical Center of Serbia	Belgrade
Serbia	Institute for pulmonary diseases of Vojvodina	Sremska Kamenica
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología	La Coruña
Spain	Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas
Spain	Fundacion Jimenez Diaz; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Puerta de Hierro; Servicio de Oncologia	Majadahonda	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Hospital Universitario Miguel Servet; Servicio Oncologia	Zaragoza
Sweden	Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken	Goeteborg
Sweden	Universitetssjukhuset Linköping; Lungmedicinkliniken	Linköping
Sweden	Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02	Stockholm
Switzerland	Kantonsspital Baden; Medizinische Klinik, Onkologie	Baden
Switzerland	HUG; Oncologie	Geneve
Switzerland	Luzerner Kantonsspital; Medizinische Onkologie	Luzern
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan Uni Hospital; Internal Medicine	Taipei
Taiwan	Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology	Taoyuan
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Turkey	Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology	Istanbul
Turkey	Izmir Suat Seren Chest Diseases and Surgery Research Hospital	Izmir
Ukraine	State Medical Academy; Oncology	Dnipropetrovsk
Ukraine	Karkiv Regional Oncology Center	Kharkiv
Ukraine	Uzhgorod Nat. University Central Municip Hosp; Onc Center	Uzhgorod
United Kingdom	Diana Princess of Wales Hosp.	Grimsby
United Kingdom	Charing Cross Hospital	London
United Kingdom	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Kings Mill Hospital	Sutton in Ashfield
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	Texas Onc-Central Austin CA Ct	Austin	Texas
United States	Comprehensive Blood/Cancer Ctr	Bakersfield	California
United States	Hematology-Oncology; Associates of the Quad Cities	Bettendorf	Iowa
United States	Billings Clinic; Research Center	Billings	Montana
United States	Roswell Park Cancer Inst.	Buffalo	New York
United States	Roy & Patricia Disney Family Cancer Center	Burbank	California
United States	New York Oncology Hematology PC - Latham	Clifton Park	New York
United States	Mid Ohio Onc Hematology Inc	Columbus	Ohio
United States	Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building	Detroit	Michigan
United States	Willamette Valley Cancer Ctr - 520 Country Club	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Summit Medical Center	Florham Park	New Jersey
United States	St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr	Fullerton	California
United States	St. Mary's Hospital Regional Cancer Center	Grand Junction	Colorado
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Kaiser Permanente - Hayward	Hayward	California
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	The Methodist Cancer Center	Houston	Texas
United States	Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)	Jacksonville	Florida
United States	Scripps Clinic; Hematology & Oncology	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada - Eastern Avenue	Las Vegas	Nevada
United States	Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree	Lone Tree	Colorado
United States	Pacific Shores Medical Group	Long Beach	California
United States	Univ of Calif, Los Angeles; Hematology/Oncology	Los Angeles	California
United States	AMPM Research Clinic	Miami	Florida
United States	Aurora Health Care; Patient Centered Research	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	US Oncology Research at Minnesota Oncology	Minneapolis	Minnesota
United States	Montana Cancer Specialists	Missoula	Montana
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr	Northridge	California
United States	Kaiser Permanente - Oakland	Oakland	California
United States	Oncology Hematology West Midwest	Omaha	Nebraska
United States	Orlando Health Inc.	Orlando	Florida
United States	Luckow Pavillion, Valley Hosp; Office of Clinical Trials	Paramus	New Jersey
United States	Illinois Cancer Care	Peoria	Illinois
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Quincy Medical Group	Quincy	Illinois
United States	TMPN/ Cancer Care Associates	Redondo Beach	California
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	Kaiser Permanente - Roseville	Roseville	California
United States	Kaiser Permanente Sacramento Medical Center	Sacramento	California
United States	UC Davis; Comprehensive Cancer Center	Sacramento	California
United States	Kaiser Permanente - San Francisco (2238 Geary)	San Francisco	California
United States	K. Permanente - San Jose	San Jose	California
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Kaiser Permanente - San Marcos	San Marcos	California
United States	K. Permanente - Santa Clara	Santa Clara	California
United States	Central Coast Medical Oncology	Santa Maria	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	K. Permanente - S. San Fran	South San Francisco	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Cancer Treatment Centers of America-Tulsa	Tulsa	Oklahoma
United States	Texas Oncology, P.A. - Tyler; Tyler Cancer Center	Tyler	Texas
United States	Kaiser Permanente - Vallejo	Vallejo	California
United States	Northwest Cancer Specialists - Vancouver	Vancouver	Washington
United States	K. Permanente - Walnut Creek	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Canada,  Chile,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Norway,  Panama,  Poland,  Portugal,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Died: PP-ITT		Baseline until death due to any cause (up to approximately 2.25 years)
Primary	Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP	Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.	Baseline until death due to any cause (up to approximately 2.25 years)
Primary	Overall Survival (OS): PP-ITT	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death due to any cause (up to approximately 2.25 years)
Primary	OS: TC1/2/3 or IC1/2/3 Subgroup of PP	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death due to any cause (up to approximately 2.25 years)
Primary	OS: SP-ITT	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death due to any cause (up to approximately 2.87 years)
Primary	OS: TC1/2/3 Or IC1/2/3 Subgroup of SP	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death from any cause (approximately 2.87 years)
Primary	OS: TC2/3 or IC2/3 Subgroup of SP	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death due to any cause (up to approximately 2.87 years)
Primary	OS: TC3 or IC3 Subgroup of SP	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.	Baseline until death due to any cause (up to approximately 2.87 years)
Secondary	Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.	Baseline up to PD or Death (up to approximately 2.25 years)
Secondary	Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.	Baseline up to PD or Death (up to approximately 2.25 years)
Secondary	Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. 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. No new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP	Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. 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. No new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.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.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.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.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab		Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
Secondary	Maximum Observed Serum Atezolizumab Concentration (Cmax)		Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
Secondary	Minimum Observed Serum Atezolizumab Concentration (Cmin)		Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
Secondary	Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)	TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
Secondary	EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items	EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-C30 Questionnaire Score: Functional Subscales	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-C30 Questionnaire Score: GHS Scale	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-C30 Questionnaire Score: Symptom Subscale	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Alopecia	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Coughing	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Dysphagia	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Dyspnea	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Hemoptysis	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Pain in Chest	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	EORTC QLQ-LC13 Questionnaire Score: Sore Mouth	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary	PFS as Determined by Investigator Using RECIST v1.1: SP-ITT	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. 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. No new lesions.	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary	DOR as Determined by Investigator Using RECIST v1.1: SP ITT	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.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.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)