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 (OAK)

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 1225
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina
    • Instituto Médico Río Cuarto
  • Provincia De Buenos Aires, Argentina, B1884BBF
    • COIBA
  • Rosario, Argentina, S2000KZE
    • Instituto de Oncología de Rosario
• Austria
  • Innsbruck, Austria, 6020
    • Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Vöcklabruck, Austria, 4840
    • Lkh Vöcklabruck; I. Abt. Für Innere Medizin
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Cite de La Sante de Laval; Hemato-Oncologie
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
• Chile
  • Recoleta, Chile, 8420383
    • Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
  • Temuco, Chile, 4810469
    • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Vina Del Mar, Chile, 2520598
    • ONCOCENTRO APYS; Oncología
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital; Dep. of Pulmonary Medicine
  • Oulu, Finland, 90029
    • Oulu University Hospital; Oncology
  • Tampere, Finland, 33520
    • Tampere University Hospital; Dept of Oncology
• France
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Pneumologie
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Creteil, France, 94010
    • Centre Hospitalier Intercommunal; Service de Pneumologie
  • Grenoble, France, 38043
    • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
  • Le Mans, France, 72000
    • Centre Jean Bernard; Radiotherapie Chimiotherapie
  • Lille, France, 59020
    • Centre OSCAR LAMBRET
  • Marseille, France, 13915
    • Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
  • Mulhouse, France, 68070
    • Hopital Emile Muller;Pneumologie
  • Paris, France, 75970
    • Hopital Tenon;Pneumologie
  • Paris, France, 75014
    • Hopital Cochin; Unite Fonctionnelle D Oncologie
  • Paris, France, 75475
    • Hopital Saint Louis; Oncologie Medicale
  • Paris, France, 75674
    • GH Paris Saint Joseph; Pneumologie
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud; Pneumologie
  • Pringy, France, 74374
    • CH De La Region D Annecy
  • Rennes, France, 35033
    • Hopital de Pontchaillou; Service de Pneumologie
  • Strasbourg, France, 67065
    • Centre Paul Strauss; Oncologie Medicale
  • Suresnes, France, 92151
    • Hopital Foch; Pneumologie
  • Toulon, France, 83041
    • Hia Sainte Anne; Pneumologie
  • Toulouse, France, 31059
    • Hopital Larrey; Pneumologie
• Germany
  • Berlin, Germany, 14165
    • Helios Klinikum Emil von Behring GmbH
  • Frankfurt, Germany, 60488
    • Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
  • Gauting, Germany, 82131
    • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Köln, Germany, 51109
    • Krankenhaus Merheim Lungenklinik
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
• Greece
  • Athens, Greece, 115 27
    • Uoa Sotiria Hospital; Oncology
  • Patras, Greece, 265 04
    • University Hospital of Patras Medical Oncology
  • Thermi Thessalonikis, Greece, 570 01
    • Thermi Clinic; Oncology Clinic
• Guatemala
  • Guatemala City, Guatemala, 01015
    • Grupo Angeles
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem X; Pulmonologiai Klinika
  • Pecs, Hungary, 7624
    • University of Pecs, I st Dept of Internal Medicine
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • Azienda Ospedaliera San Giuseppe Moscati
    • Napoli, Campania, Italy, 80131
      • Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • Azienda Ospedaliera Univ Parma; Dept Oncologia Medica
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
  • Lombardia
    • Milano, Lombardia, Italy, 20141
      • Istituto Europeo Di Oncologia
    • Milano, Lombardia, Italy, 20132
      • Irccs Ospedale San Raffaele;Oncologia Medica
    • Monza, Lombardia, Italy, 20900
      • ASST DI MONZA; Oncologia Medica
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  • Sicilia
    • Catania, Sicilia, Italy, 95100
      • POLICLINICO RODOLICO, U.O. di Oncologia Medica
  • Toscana
    • Lucca, Toscana, Italy, 55100
      • Ospedale San Luca; Oncologia
    • Pisa, Toscana, Italy, 56124
      • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
    • Verona, Veneto, Italy, 37134
      • A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital; Respiratory Medicine
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East; Thoracic Oncology
  • Ehime, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center; Internal Medicine
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
  • Hyogo, Japan, 650-0047
    • Kobe City Medical Center General Hospital; Respiratory Medicine
  • Hyogo, Japan, 673-8558
    • Hyogo Cancer Center; Thoracic Oncology
  • Miyagi, Japan, 981-1293
    • Miyagi Cancer Center; Respiratory Medicine
  • Okayama, Japan, 700-8558
    • Okayama University Hospital; Respiratory and Allergy Medicine
  • Osaka, Japan, 589-8511
    • Kindai University Hospital; Medical Oncology
  • Osaka, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center; Thoracic Oncology
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center; Thoracic Oncology
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR, Respiratory Medicine
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital; Thoracic Medical Oncology
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital; Dept of Surgery
  • Yamaguchi, Japan, 755-0241
    • National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 410-769
    • National Cancer Center; Medical Oncology
  • Gyeonggi-do, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital; Hematology Medical Oncology
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Severance Hospital; Medical Oncology
  • Seoul, Korea, Republic of, 137-807
    • Seoul St.Mary's Hospital; Medical Oncology
  • Seoul, Korea, Republic of, 03080
    • Seoul National Uni Hospital; Internal Medicine
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center; Gastroenterology
• Netherlands
  • 'S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis; Dept of Lung Diseases
  • Nieuwegein, Netherlands, 3435 CM
    • Antonius Ziekenhuis; Dept of Lung Diseases
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital; Dept of Medical Oncology
• Norway
  • Oslo, Norway, 0310
    • Oslo Universitetssykehus HF; Radiumhospitalet
• Panama
  • Panama, Panama, 0832
    • Centro Hemato Oncologico Panama
• Poland
  • Gdansk, Poland, 80-952
    • Medical University of Gdansk
  • Lodz, Poland, 93-513
    • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Poznan, Poland, 60-693
    • Med.-Polonia Sp. z o.o. NSZOZ
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
• Portugal
  • Coimbra, Portugal, 3041-801
    • Hospital Geral; Servico de Pneumologia
  • Lisboa, Portugal, 1796-001
    • Hospital Pulido Valente; Servico de Pneumologia
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Russian Federation
  • Moscow, Russian Federation, 105229
    • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
  • Saint-Petersburg, Russian Federation, 198255
    • City Clinical Onc.
  • Samara, Russian Federation, 443031
    • SBI of Healthcare Samara Regional Clinical Oncology Dispensary
• Serbia
  • Belgrade, Serbia, 11000
    • Clinic for Pulmonology, Clinical Center of Serbia
  • Sremska Kamenica, Serbia, 21204
    • Institute For Pulmonary Diseases of Vojvodina
• Spain
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
• Sweden
  • Goeteborg, Sweden, 41345
    • Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
  • Linköping, Sweden, 581 85
    • Universitetssjukhuset Linköping; Lungmedicinkliniken
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden; Medizinische Klinik, Onkologie
  • Geneve, Switzerland, 1211
    • HUG; Oncologie
  • Luzern, Switzerland, 6004
    • Luzerner Kantonsspital; Medizinische Onkologie
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan Uni Hospital; Internal Medicine
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital; Medical Oncology
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
• Turkey
  • Istanbul, Turkey, 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Izmir, Turkey, 35110
    • Izmir Suat Seren Chest Diseases and Surgery Research Hospital
• Ukraine
  • Dnipropetrovsk, Ukraine, 43102
    • State Medical Academy; Oncology
  • Kharkiv, Ukraine, 61070
    • Karkiv Regional Oncology Center
  • Uzhgorod, Ukraine, 88000
    • Uzhgorod Nat. University Central Municip Hosp; Onc Center
• United Kingdom
  • Grimsby, United Kingdom, DN33 2BA
    • Diana Princess of Wales Hosp.
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • London, United Kingdom, NW1 - 2PG
    • University College London Hospital
  • London, United Kingdom, NW3 2QS
    • Royal Free Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Trust
  • Sutton in Ashfield, United Kingdom, NG17 4JL
    • Kings Mill Hospital
• United States
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood/Cancer Ctr
    • Burbank, California, United States, 91505
      • Roy & Patricia Disney Family Cancer Center
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
    • Hayward, California, United States, 94545
      • Kaiser Permanente - Hayward
    • La Jolla, California, United States, 92037-1027
      • Scripps Clinic; Hematology & Oncology
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90095
      • Univ of Calif, Los Angeles; Hematology/Oncology
    • Northridge, California, United States, 91328
      • North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
    • Oakland, California, United States, 94611
      • Kaiser Permanente - Oakland
    • Redondo Beach, California, United States, 90277
      • TMPN/ Cancer Care Associates
    • Roseville, California, United States, 95661
      • Kaiser Permanente - Roseville
    • Sacramento, California, United States, 95814
      • Kaiser Permanente Sacramento Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis; Comprehensive Cancer Center
    • San Francisco, California, United States, 94115
      • Kaiser Permanente - San Francisco (2238 Geary)
    • San Jose, California, United States, 95119
      • K. Permanente - San Jose
    • San Luis Obispo, California, United States, 93401
      • Coastal Integrative Cancer Care
    • San Marcos, California, United States, 92069
      • Kaiser Permanente - San Marcos
    • Santa Clara, California, United States, 95051
      • K. Permanente - Santa Clara
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology
    • South San Francisco, California, United States, 94080
      • K. Permanente - S. San Fran
    • Vallejo, California, United States, 94589
      • Kaiser Permanente - Vallejo
    • Walnut Creek, California, United States, 94596
      • K. Permanente - Walnut Creek
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • St. Mary's Hospital Regional Cancer Center
    • Lone Tree, Colorado, United States
      • Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
    • Miami, Florida, United States, 33145
      • AMPM Research Clinic
    • Orlando, Florida, United States, 32806
      • Orlando Health Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Hematology-Oncology; Associates of the Quad Cities
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • US oncology research at Minnesota Oncology
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic; Research Center
    • Missoula, Montana, United States, 59802
      • Montana Cancer Specialists
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West Midwest
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Center
    • Paramus, New Jersey, United States, 07652
      • Luckow Pavillion, Valley Hosp; Office of Clinical Trials
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • San Juan Oncology Associates
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Inst.
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology PC - Latham
  • Ohio
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Onc Hematology Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America-Tulsa
  • Oregon
    • Eugene, Oregon, United States, 97401-8122
      • Willamette Valley Cancer Ctr - 520 Country Club
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Onc-Central Austin CA Ct
    • Houston, Texas, United States, 77030
      • The Methodist Cancer Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology, P.A. - Tyler; Tyler Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists - Vancouver
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care; Patient Centered Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody; Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.	Drug: Atezolizumab; 1200 mg IV infusion on Day 1 of each 21-day cycle; Other Names: Tecentriq
Active Comparator: Docetaxel; Docetaxel 75 milligrams per meter square (mg/m^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.	Drug: Docetaxel; 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Died: PP-ITT		Baseline until death due to any cause (up to approximately 2.25 years)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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])
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21.
• Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30.
• Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882.
• Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.
• Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.
• Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.
• Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.
• Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.
• Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum In: Lancet. 2017 Apr 8;389(10077):e5.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2014
• Primary Completion (Actual): July 7, 2016
• Study Completion (Actual): January 9, 2019

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Atezolizumab
• Other Study ID Numbers: GO28915; 2013-003331-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No