A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Last updated: July 15, 2021
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02367781
GO29537
2014-003206-32
  • Ages > 18
  • All Genders

Study Summary

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
  • Participants with no prior treatment for Stage IV non-squamous NSCLC
  • Previously obtained archival tumor tissue or tissue obtained from fresh biopsy atscreening
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion

Exclusion Criteria: Cancer-Specific Exclusions:

  • Active or untreated central nervous system metastases
  • Malignancies other than NSCLC within 5 years prior to randomization, with theexception of those with a negligible risk of metastasis or death treated with expectedcurative outcome General Medical Exclusions:
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screeningchest computed tomography scan. History of radiation pneumonitis in the radiationfield (fibrosis) is permitted
  • Positive test for human immunodeficiency virus
  • Active hepatitis B or hepatitis C
  • Severe infection within 4 weeks prior to randomization
  • Significant cardiovascular disease
  • Illness or condition that interferes with the participant's capacity to understand,follow and/or comply with study procedures Exclusion Criteria Related to Medications:
  • Prior treatment with cluster of differentiation 137 agonists or immune checkpointblockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

Study Design

Total Participants: 723
Study Start date:
April 16, 2015
Estimated Completion Date:
January 18, 2021

Connect with a study center

  • empty

    Antwerpen, 2018
    Belgium

    Site Not Available

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • CHU Ambroise Paré

    Mons, 7000
    Belgium

    Site Not Available

  • Werken Glorieux VZW

    Ronse, 9600
    Belgium

    Site Not Available

  • GasthuisZusters Antwerpen

    Wilrijk, 2610
    Belgium

    Site Not Available

  • BC Cancer - Surrey

    Surrey, British Columbia V3V 1Z2
    Canada

    Site Not Available

  • Royal Victoria Regional Health Centre

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • empty

    East York, Ontario M4C 3E7
    Canada

    Site Not Available

  • William Osler Health Centre

    Etobicoke, Ontario M9V 1R8
    Canada

    Site Not Available

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300
    France

    Site Not Available

  • Institut Hospitalier Franco-Britannique; Cancerologie

    Levallois-Perret, 92300
    France

    Site Not Available

  • Fondation Hopital Saint Joseph;Cardiologie Clinique

    Marseille, 13285
    France

    Site Not Available

  • CHR Metz Thionville Hopital Notre Dame de Bon Secours

    Metz, 57038
    France

    Site Not Available

  • Clinique Clementville; Hopital De Jour

    Montpellier, 34070
    France

    Site Not Available

  • Centre D'oncologie de Gentilly; Service Oncologie Medicale

    Nancy, 54100
    France

    Site Not Available

  • Clinique Catherine de Sienne

    Nantes, 44202
    France

    Site Not Available

  • Hopital American de Paris (American Hospital of Paris)

    Neuilly sur Seine, 92200
    France

    Site Not Available

  • HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

    Orleans, 45100
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

    Saint Pierre, 97448
    France

    Site Not Available

  • Hopital d'Instruction des Armees de Begin

    Saint-Mande, 94160
    France

    Site Not Available

  • CHRU Nancy; Pneumologie

    Vandoeuvre-lès-nancy, 54511
    France

    Site Not Available

  • Centre Hospitalier Bretagne Atlantique Vannes

    Vannes, 56017
    France

    Site Not Available

  • Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie

    Berlin, 13353
    Germany

    Site Not Available

  • DIAKO Evangelische Diakonie Krankenhaus gGmbH

    Bremen, 28239
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Site Not Available

  • Bezirksklinikum Obermain

    Ebensfeld, 96250
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt, 99089
    Germany

    Site Not Available

  • St. Antonius Hospital

    Eschweiler, 52249
    Germany

    Site Not Available

  • Klinikum Esslingen GmbH; Frauenklinik

    Esslingen Am Neckar, 73730
    Germany

    Site Not Available

  • Malteser Krankenhaus St. Franziskus-Hospital

    Flensburg, 24939
    Germany

    Site Not Available

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488
    Germany

    Site Not Available

  • Asklepios Fachkliniken GmbH

    Gauting, 82131
    Germany

    Site Not Available

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548
    Germany

    Site Not Available

  • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

    Gerlingen, 70839
    Germany

    Site Not Available

  • Universität Greifswald

    Greifwald,
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126
    Germany

    Site Not Available

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376
    Germany

    Site Not Available

  • St. Vincentius Kliniken Karlsruhe

    Karlsruhe, 76137
    Germany

    Site Not Available

  • Klinikum Kassel; Hautklinik

    Kassel, 34125
    Germany

    Site Not Available

  • Katholisches Klinikum Marienhof

    Koblenz Am Rhein, 56073
    Germany

    Site Not Available

  • Klinikum Leverkusen GmbH

    Leverkusen, 51375
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

    Lubeck, 23538
    Germany

    Site Not Available

  • empty

    Luebeck, 23538
    Germany

    Site Not Available

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167
    Germany

    Site Not Available

  • Johannes Wesling Klinikum Minden

    Minden, 32429
    Germany

    Site Not Available

  • empty

    Monchengladbach, 41063
    Germany

    Site Not Available

  • LMU Klinikum der Universitat Munchen

    Munchen, 80337
    Germany

    Site Not Available

  • KH Maria Hilf Franziskushaus

    Mönchengladbach, 41063
    Germany

    Site Not Available

  • empty

    München, 81675
    Germany

    Site Not Available

  • empty

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Universitatsklinikum Ulm; Klinik fur Innere Medizin II

    Ulm, 89081
    Germany

    Site Not Available

  • Praxis fur Haematologie und Internistische Onkologie

    Velbert, 42551
    Germany

    Site Not Available

  • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

    Villingen-Schwenningen, 78052
    Germany

    Site Not Available

  • Helios Klinik Wuppertal

    Wuppertal, 42283
    Germany

    Site Not Available

  • Dres. Christoph Maintz und Christiane Hinske

    Wurselen, 52146
    Germany

    Site Not Available

  • MVZ West GmbH Wuerselen Haematologie-Onkologie

    Würselen, 52146
    Germany

    Site Not Available

  • Prince of Wales Hosp; Dept. Of Clinical Onc

    Shatin,
    Hong Kong

    Site Not Available

  • Soroka University Medical Centre

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Beer Yaakov, 70300
    Israel

    Site Not Available

  • Soroka University Medical Centre

    Beer-Sheva, 84101
    Israel

    Site Not Available

  • empty

    Haifa, 4959381
    Israel

    Site Not Available

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000
    Israel

    Site Not Available

  • Meir Medical Center; Oncology

    Kfar-Saba, 4428164
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • empty

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tiqwa, 49100
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • empty

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Rambam Health Corporation; Oncology Institute

    Rambam, 3525408
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 7610001
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Ctr; Oncology

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Tel Hashomer, 52661
    Israel

    Site Not Available

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo 66100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, Campania 83100
    Italy

    Site Not Available

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Ospedale Di Macerata; Oncologia

    Macerata, Marche 62100
    Italy

    Site Not Available

  • Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

    Perugia, Umbria 06129
    Italy

    Site Not Available

  • Consorcio Hospitalario Provincial de Castellon

    Castello de la Plana, Castellon 012002
    Spain

    Site Not Available

  • Consorcio Hospitalario Provincial de Castellon

    Castellon DE LA Plana/castello DE LA Plana, Castellon 12002
    Spain

    Site Not Available

  • Consorcio Hospitalario Provincial de Castellon

    Castellon de la Plana, Castellon 12002
    Spain

    Site Not Available

  • Hospital Son Llatzer

    Palma de Mallorca, Islas Baleares 07198
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruña 15006
    Spain

    Site Not Available

  • Hospital Universitario de Torrejon

    Torrejon de Ardoz, Madrid 28850
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    S. Cristobal De La Laguna, Tenerife 38320
    Spain

    Site Not Available

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital de San Pedro de Alcantara

    Caceres, 10003
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18012
    Spain

    Site Not Available

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaen

    Jaen, 23007
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital NisA 9 de Octubre

    Valencia, 46015
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009
    Spain

    Site Not Available

  • empty

    Binghamton, Alabama 35233
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Uni of Arkansas For Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Highlands Oncology Group

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California 92008
    United States

    Site Not Available

  • empty

    Los Angeles, California 90034
    United States

    Site Not Available

  • Kaiser Permanente Oakland Medical Center

    Oakland, California 94611
    United States

    Site Not Available

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California 95661
    United States

    Site Not Available

  • Kaiser Permanente - Sacramento Medical Center and Medical Offices

    Sacramento, California 95825
    United States

    Site Not Available

  • Kaiser Permanente - San Francisco Medical Center

    San Francisco, California 94118
    United States

    Site Not Available

  • Kaiser Permanente - San Jose Medical Center

    San Jose, California 95119
    United States

    Site Not Available

  • Kaiser Permanente - San Leandro Medical Center

    San Leandro, California 94577
    United States

    Site Not Available

  • Kaiser Permanente - Santa Clara

    Santa Clara, California 95051
    United States

    Site Not Available

  • Kaiser Permanente - South San Francisco

    South San Francisco, California 94080
    United States

    Site Not Available

  • Kaiser Permanente; Oncology Clinical Trials

    Vallejo, California 94589
    United States

    Site Not Available

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Greeley, Colorado 85234
    United States

    Site Not Available

  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • empty

    Bradenton, Florida 34209
    United States

    Site Not Available

  • University of Miami School of Medicine - Sylvester at Deerfield

    Deerfield Beach, Florida Suite 200
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • empty

    Ft Myers, Florida 33916
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • empty

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists East

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists East

    West Palm Bch, Florida 33401
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists East

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • University Cancer & Blood Center, LLC; Research

    Athens, Georgia 30607
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers P.C.

    Carlton, Georgia 30117
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Carrollton, Georgia 30117
    United States

    Site Not Available

  • empty

    Carrolton, Georgia 30117
    United States

    Site Not Available

  • empty

    Lawrence, Georgia 30046
    United States

    Site Not Available

  • Suburban Hematology / Oncology Associates

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Southeastern Regional Medical Center, Inc.

    Newnan, Georgia 30265
    United States

    Site Not Available

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • On Care Hawaii, Inc.

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Joliet Oncology-Hematology; Associates, Ltd.

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Loyola University Med Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Illinois Cancer Care

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Quincy Medical Group

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Southern Illinois University, Simmons Cancer Institute

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Fort Wayne Med Oncology & Hematology Inc

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242-1083
    United States

    Site Not Available

  • Siouxland Hematology/Oncology

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Kentucky Cancer Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Lahey Clinic Med Ctr

    Lexington, Kentucky 02421
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Center For Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Fredrick Smith MD

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • empty

    Boston, Massachusetts 2130
    United States

    Site Not Available

  • Southcoast Health System

    Fairhaven, Massachusetts 02719
    United States

    Site Not Available

  • empty

    Peabody, Massachusetts 01960
    United States

    Site Not Available

  • Bronson Battle Creek

    Battle Creek, Michigan 49016
    United States

    Site Not Available

  • empty

    Detroit, Michigan 48201
    United States

    Site Not Available

  • empty

    Jackson, Michigan 49201
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • CentraCare Health; Coborn Cancer Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • empty

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Hematology and Oncology Associates at Bridgepoint

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Southeast Nebraska Cancer Ctr

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Va Sierra Nevada Health Care System

    Reno, Nevada 89502
    United States

    Site Not Available

  • Englewood Hospital and Medical Center

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Saint Barnabas Medical Center

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Cancer Inst. of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • empty

    Summitt, New Jersey 07902
    United States

    Site Not Available

  • Clinical Research Alliance

    Lake Success, New York 11042
    United States

    Site Not Available

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York 10016
    United States

    Site Not Available

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Site Not Available

  • Presbyterian Hospital

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke University Medical Center; Department of Medicine

    Durham, North Carolina 27710
    United States

    Site Not Available

  • empty

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • W.G. Bill Hefner VA Medical Center

    Salisbury, North Carolina
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Mark H. Zangmeister Center

    Columbus, Ohio 43219
    United States

    Site Not Available

  • Oncology Hematology Care, Inc.

    Hamilton, Ohio 45103
    United States

    Site Not Available

  • Pinnacle Health

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • empty

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Greenville Health System; Cancer Center

    Greenville, South Carolina 29605-4292
    United States

    Site Not Available

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • University Oncology Associates

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • SCRI The Center For Cancer and Blood Disorders

    Denton, Texas 76210
    United States

    Site Not Available

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Cancer Care Network of South Texas - SAT & BC

    San Antonio, Texas 78217
    United States

    Site Not Available

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