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
2 other identifiers
interventional
1,225
30 countries
206
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2014
Longer than P75 for phase_3
206 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedStudy Start
First participant enrolled
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2016
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2019
CompletedDecember 20, 2019
December 1, 2019
2.3 years
December 6, 2013
May 8, 2017
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (29)
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
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
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
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
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
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
- +24 more secondary outcomes
Study Arms (2)
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
EXPERIMENTALAtezolizumab 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.
Docetaxel
ACTIVE COMPARATORDocetaxel 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.
Interventions
1200 mg IV infusion on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (208)
Comprehensive Blood/Cancer Ctr
Bakersfield, California, 93309, United States
Roy & Patricia Disney Family Cancer Center
Burbank, California, 91505, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, 92835, United States
Kaiser Permanente - Hayward
Hayward, California, 94545, United States
Scripps Clinic; Hematology & Oncology
La Jolla, California, 92037-1027, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Univ of Calif, Los Angeles; Hematology/Oncology
Los Angeles, California, 90095, United States
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
Northridge, California, 91328, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
TMPN/ Cancer Care Associates
Redondo Beach, California, 90277, United States
Kaiser Permanente - Roseville
Roseville, California, 95661, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95814, United States
UC Davis; Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco, California, 94115, United States
K. Permanente - San Jose
San Jose, California, 95119, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Kaiser Permanente - San Marcos
San Marcos, California, 92069, United States
K. Permanente - Santa Clara
Santa Clara, California, 95051, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
K. Permanente - S. San Fran
South San Francisco, California, 94080, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
K. Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree
Lone Tree, Colorado, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, 32256, United States
AMPM Research Clinic
Miami, Florida, 33145, United States
Orlando Health Inc.
Orlando, Florida, 32806, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Hematology-Oncology; Associates of the Quad Cities
Bettendorf, Iowa, 52722, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
Detroit, Michigan, 48201, United States
US Oncology Research at Minnesota Oncology
Minneapolis, Minnesota, 55404, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Billings Clinic; Research Center
Billings, Montana, 59101, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Oncology Hematology West Midwest
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89014, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, 89169, United States
Summit Medical Center
Florham Park, New Jersey, 07932, United States
Luckow Pavillion, Valley Hosp; Office of Clinical Trials
Paramus, New Jersey, 07652, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Roswell Park Cancer Inst.
Buffalo, New York, 14263, United States
New York Oncology Hematology PC - Latham
Clifton Park, New York, 12065, United States
Mid Ohio Onc Hematology Inc
Columbus, Ohio, 43219, United States
Cancer Treatment Centers of America-Tulsa
Tulsa, Oklahoma, 74133, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, 97401-8122, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Texas Onc-Central Austin CA Ct
Austin, Texas, 78731, United States
The Methodist Cancer Center
Houston, Texas, 77030, United States
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler, Texas, 75702, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Aurora Health Care; Patient Centered Research
Milwaukee, Wisconsin, 53215, United States
Instituto Medico Rio Cuarto
Córdoba, Argentina
COIBA
Provincia de Buenos Aires, B1884BBF, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
Innsbruck, 6020, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Lkh Vöcklabruck; I. Abt. Für Innere Medizin
Vöcklabruck, 4840, Austria
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, H7M 3L9, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta, 8420383, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, 4810469, Chile
ONCOCENTRO APYS; Oncología
Viña del Mar, 2520598, Chile
Helsinki University Central Hospital; Dep. of Pulmonary Medicine
Helsinki, 00290, Finland
Oulu University Hospital; Oncology
Oulu, 90029, Finland
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Institut Sainte Catherine
Avignon, 84918, France
Hopital Jean Minjoz; Pneumologie
Besançon, 25030, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077, France
Centre Francois Baclesse
Caen, 14076, France
Centre Hospitalier Intercommunal; Service de Pneumologie
Créteil, 94010, France
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, 38043, France
Centre Jean Bernard; Radiotherapie Chimiotherapie
Le Mans, 72000, France
Centre Oscar Lambret
Lille, 59020, France
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille, 13915, France
Hopital Emile Muller;Pneumologie
Mulhouse, 68070, France
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, 75014, France
Hopital Saint Louis; Oncologie Medicale
Paris, 75475, France
GH Paris Saint Joseph; Pneumologie
Paris, 75674, France
Hopital Tenon;Pneumologie
Paris, 75970, France
Centre Hospitalier Lyon Sud; Pneumologie
Pierre-Bénite, 69495, France
CH de la region d Annecy
Pringy, 74374, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes, 35033, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Hopital Foch; Pneumologie
Suresnes, 92151, France
Hia Sainte Anne; Pneumologie
Toulon, 83041, France
Hopital Larrey; Pneumologie
Toulouse, 31059, France
Helios Klinikum Emil von Behring GmbH
Berlin, 14165, Germany
Krankenhaus Merheim Lungenklinik
Cologne, 51109, Germany
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, 60488, Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, 82131, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, 06120, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Fachklinik für Lungenerkrankungen
Immenhausen, 34376, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, 93053, Germany
Uoa Sotiria Hospital; Oncology
Athens, 115 27, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Thermi Clinic; Oncology Clinic
Thermi Thessalonikis, 570 01, Greece
Grupo Angeles
Guatemala City, 01015, Guatemala
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, 1083, Hungary
University of Pecs, I st Dept of Internal Medicine
Pécs, 7624, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100, Italy
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli, Campania, 80131, Italy
Azienda Ospedaliera Univ Parma; Dept Oncologia Medica
Parma, Emilia-Romagna, 43100, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato
Udine, Friuli Venezia Giulia, 33100, Italy
Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
Rome, Lazio, 00168, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genoa, Liguria, 16132, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, 20132, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900, Italy
POLICLINICO RODOLICO, U.O. di Oncologia Medica
Catania, Sicily, 95100, Italy
Ospedale San Luca; Oncologia
Lucca, Tuscany, 55100, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, 56124, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padua, Veneto, 35128, Italy
A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
Verona, Veneto, 37134, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, 464-8681, Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka, 811-1395, Japan
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyōgo, 650-0047, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyōgo, 673-8558, Japan
Miyagi Cancer Center; Respiratory Medicine
Miyagi, 981-1293, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, 700-8558, Japan
Kindai University Hospital; Medical Oncology
Osaka, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
Osaka, 591-8555, Japan
Saitama Cancer Center; Thoracic Oncology
Saitama, 362-0806, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, 411-8777, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, 135-8550, Japan
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, 160-0023, Japan
National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine
Yamaguchi, 755-0241, Japan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven, 5623 EJ, Netherlands
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein, 3435 CM, Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, 1023, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital; Dept of Medical Oncology
Hamilton, 3240, New Zealand
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, 0310, Norway
Centro Hemato Oncologico Panama
Panama City, 0832, Panama
Medical University of Gdansk
Gdansk, 80-952, Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, 93-513, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock, 05-400, Poland
Med.-Polonia Sp. z o.o. NSZOZ
Poznan, 60-693, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
Hospital Geral; Servico de Pneumologia
Coimbra, 3041-801, Portugal
Hospital Pulido Valente; Servico de Pneumologia
Lisbon, 1796-001, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, 105229, Russia
City Clinical Onc.
Saint Petersburg, 198255, Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for pulmonary diseases of Vojvodina
Kamenitz, 21204, Serbia
National Cancer Center; Medical Oncology
Gyeonggi-do, 410-769, South Korea
Seoul National University Bundang Hospital; Hematology Medical Oncology
Gyeonggi-do, 463-707, South Korea
Seoul National Uni Hospital; Internal Medicine
Seoul, 03080, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
Samsung Medical Center; Gastroenterology
Seoul, 135-710, South Korea
Seoul St.Mary's Hospital; Medical Oncology
Seoul, 137-807, South Korea
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, 15006, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
Gothenburg, 41345, Sweden
Universitetssjukhuset Linköping; Lungmedicinkliniken
Linköping, 581 85, Sweden
Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02
Stockholm, 171 76, Sweden
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden, 5404, Switzerland
HUG; Oncologie
Geneva, 1211, Switzerland
Luzerner Kantonsspital; Medizinische Onkologie
Lucerne, 6004, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan Uni Hospital; Internal Medicine
Taipei, 100, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan District, 333, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Izmir Suat Seren Chest Diseases and Surgery Research Hospital
Izmir, 35110, Turkey (Türkiye)
State Medical Academy; Oncology
Dnipropetrovsk, 43102, Ukraine
Karkiv Regional Oncology Center
Kharkiv, 61070, Ukraine
Uzhgorod Nat. University Central Municip Hosp; Onc Center
Uzhhorod, 88000, Ukraine
Diana Princess of Wales Hosp.
Grimsby, DN33 2BA, United Kingdom
University College London Hospital
London, NW1 - 2PG, United Kingdom
Royal Free Hospital
London, NW3 2QS, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Kings Mill Hospital
Sutton in Ashfield, NG17 4JL, United Kingdom
Related Publications (14)
Melchionna R, Di Modugno F, Di Carlo A, D'Ambrosio L, Palermo B, Tocci A, Paolini F, Sperduti I, Campo G, Taje R, Gallina F, Visca P, D'Andrea D, Nistico P. Reciprocal regulation of hMENA and TGF-beta signaling in cancer-associated fibroblasts promotes EMT, immunosuppression, poor prognosis, and ICT resistance in NSCLC. J Immunother Cancer. 2026 Jan 27;14(1):e013098. doi: 10.1136/jitc-2025-013098.
PMID: 41592891DERIVEDMhatre SK, Machado RJM, Ton TGN, Trinh H, Mazieres J, Rittmeyer A, Bretscher MT. Real-World Progression-Free Survival as an Endpoint in Lung Cancer: Replicating Atezolizumab and Docetaxel Arms of the OAK Trial Using Real-World Data. Clin Pharmacol Ther. 2023 Dec;114(6):1313-1322. doi: 10.1002/cpt.3045. Epub 2023 Sep 28.
PMID: 37696652DERIVEDSaal J, Bald T, Eckstein M, Ritter M, Brossart P, Ellinger J, Holzel M, Klumper N. Early C-reactive protein kinetics predicts immunotherapy response in non-small cell lung cancer in the phase III OAK trial. JNCI Cancer Spectr. 2023 Mar 1;7(2):pkad027. doi: 10.1093/jncics/pkad027.
PMID: 37004206DERIVEDDong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649.
PMID: 36428744DERIVEDCortellini 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.
PMID: 35727053DERIVEDGadgeel 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.
PMID: 34226144DERIVEDGandara 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.
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PMID: 27979383DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
March 11, 2014
Primary Completion
July 7, 2016
Study Completion
January 9, 2019
Last Updated
December 20, 2019
Results First Posted
July 2, 2017
Record last verified: 2019-12