Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1225

Study ID:

NCT02008227

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 204 Locations for this study

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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, 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, 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 , B1884, Argentina
Instituto de Oncología de Rosario
Rosario , S2000, 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 RS, 90035, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval Quebec, H7M 3, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal Quebec, H3T 1, Canada
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta , 84203, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco , 48104, Chile
ONCOCENTRO APYS; Oncología
Vina Del Mar , 25205, 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
Besancon , 25030, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux , 33077, France
Centre Francois Baclesse
Caen , 14076, France
Centre Hospitalier Intercommunal; Service de Pneumologie
Creteil , 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 Benite , 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 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
Krankenhaus Merheim Lungenklinik
Köln , 51109, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg , 93053, Germany
Uoa Sotiria Hospital; Oncology
Athens , 115 2, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Thermi Clinic; Oncology Clinic
Thermi Thessalonikis , 570 0, Greece
Grupo Angeles
Guatemala City , 01015, Guatemala
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest , 1083, Hungary
University of Pecs, I st Dept of Internal Medicine
Pecs , 7624, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
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
Roma Lazio, 00168, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova Liguria, 16132, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
ASST DI MONZA; Oncologia Medica
Monza Lombardia, 20900, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
POLICLINICO RODOLICO, U.O. di Oncologia Medica
Catania Sicilia, 95100, Italy
Ospedale San Luca; Oncologia
Lucca Toscana, 55100, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa Toscana, 56124, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova 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 , 464-8, Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba , 277-8, Japan
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime , 791-0, Japan
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka , 811-1, Japan
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo , 650-0, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyogo , 673-8, Japan
Miyagi Cancer Center; Respiratory Medicine
Miyagi , 981-1, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama , 700-8, Japan
Kindai University Hospital; Medical Oncology
Osaka , 589-8, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
Osaka , 591-8, Japan
Saitama Cancer Center; Thoracic Oncology
Saitama , 362-0, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka , 411-8, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo , 135-8, Japan
Tokyo Medical University Hospital; Dept of Surgery
Tokyo , 160-0, Japan
National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine
Yamaguchi , 755-0, Japan
National Cancer Center; Medical Oncology
Gyeonggi-do , 410-7, Korea, Republic of
Seoul National University Bundang Hospital; Hematology Medical Oncology
Gyeonggi-do , 463-7, Korea, Republic of
Seoul National Uni Hospital; Internal Medicine
Seoul , 03080, Korea, Republic of
Yonsei University Severance Hospital; Medical Oncology
Seoul , 120-7, Korea, Republic of
Samsung Medical Center; Gastroenterology
Seoul , 135-7, Korea, Republic of
Seoul St.Mary's Hospital; Medical Oncology
Seoul , 137-8, Korea, Republic of
Jeroen Bosch Ziekenhuis
'S Hertogenbosch , 5223 , Netherlands
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven , 5623 , Netherlands
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein , 3435 , 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 , 0832, Panama
Medical University of Gdansk
Gdansk , 80-95, Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz , 93-51, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock , 05-40, Poland
Med.-Polonia Sp. z o.o. NSZOZ
Poznan , 60-69, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warszawa , 02-78, Poland
Hospital Geral; Servico de Pneumologia
Coimbra , 3041-, Portugal
Hospital Pulido Valente; Servico de Pneumologia
Lisboa , 1796-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow , 10522, Russian Federation
City Clinical Onc.
Saint-Petersburg , 19825, Russian Federation
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara , 44303, Russian Federation
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade , 11000, Serbia
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
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
La 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
Malaga , 29010, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
Goeteborg , 41345, Sweden
Universitetssjukhuset Linköping; Lungmedicinkliniken
Linköping , 581 8, Sweden
Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02
Stockholm , 171 7, Sweden
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden , 5404, Switzerland
HUG; Oncologie
Geneve , 1211, Switzerland
Luzerner Kantonsspital; Medizinische Onkologie
Luzern , 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 , 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
Izmir Suat Seren Chest Diseases and Surgery Research Hospital
Izmir , 35110, Turkey
State Medical Academy; Oncology
Dnipropetrovsk , 43102, Ukraine
Karkiv Regional Oncology Center
Kharkiv , 61070, Ukraine
Uzhgorod Nat. University Central Municip Hosp; Onc Center
Uzhgorod , 88000, Ukraine
Diana Princess of Wales Hosp.
Grimsby , DN33 , United Kingdom
University College London Hospital
London , NW1 -, United Kingdom
Royal Free Hospital
London , NW3 2, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London , SE1 9, United Kingdom
St George's Hospital
London , SW17 , United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Kings Mill Hospital
Sutton in Ashfield , NG17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1225

Study ID:

NCT02008227

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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