A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

Last updated: February 11, 2019
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02409355
GO29432
2014-003106-33
  • Ages > 18
  • All Genders

Study Summary

This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IV squamous NSCLC

  • Tumor programmed death-ligand 1 (PD-L1) expression, as determined byimmunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained atscreening

  • No prior treatment for Stage IV squamous NSCLC

  • Measurable disease as defined by RECIST v1.1

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

  • Adequate hematologic and end-organ function

Exclusion

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases

  • Untreated or inadequately treated spinal cord compression

  • Leptomeningeal disease

  • Uncontrolled pleural effusion, pericardial effusion, or ascites

  • Uncontrolled tumor-related pain

  • Uncontrolled hypercalcemia

  • Any other malignancies within 5 years except those with negligible risk of metastasisor death

  • Pregnant or lactating women

  • Known hypersensitivity to any component of atezolizumab formulation or other studymedication

  • History of autoimmune disease except controlled, treated hypothyroidism or type Idiabetes

  • Prior allogeneic bone marrow or solid organ transplantation

  • Positive human immunodeficiency virus (HIV) test

  • Active hepatitis B or C

  • Active tuberculosis

  • Significant cardiovascular disease

  • Severe infection or major surgery within 4 weeks prior to randomization

  • Use of any approved anti-cancer therapy within 3 weeks prior to treatment

  • Use of an investigational agent or participation in another clinical trial within 4weeks prior to randomization

  • Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4weeks prior to randomization

  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpointblockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeuticantibodies

  • Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agentswithin 2 weeks prior to randomization

Study Design

Total Participants: 8
Study Start date:
May 07, 2015
Estimated Completion Date:
December 07, 2017

Connect with a study center

  • empty

    Salvador, BA 41820-021
    Brazil

    Site Not Available

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    Brasilia, DF 70200-730
    Brazil

    Site Not Available

  • empty

    Cachoeiro de Itapemirim, ES 29308-014
    Brazil

    Site Not Available

  • empty

    Belo Horizonte, MG 30150-221
    Brazil

    Site Not Available

  • empty

    Rio de Janeiro, RJ 20560-120
    Brazil

    Site Not Available

  • empty

    Ijui, RS 98700-000
    Brazil

    Site Not Available

  • empty

    Passo Fundo, RS 99010-260
    Brazil

    Site Not Available

  • empty

    Porto Alegre, RS 90110-270
    Brazil

    Site Not Available

  • empty

    Joinville, SC 89201-260
    Brazil

    Site Not Available

  • empty

    São Paulo, SP 01246 000
    Brazil

    Site Not Available

  • empty

    Ostrava - Poruba, 708 52
    Czech Republic

    Site Not Available

  • empty

    Prague, 180 01
    Czech Republic

    Site Not Available

  • empty

    Praha 5, 150 06
    Czech Republic

    Site Not Available

  • Multiscan s.r.o.

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Hôpital du Cluzeau

    Limoges, 87042
    France

    Site Not Available

  • Hopital Tenon; Oncologie Radiotherapie

    Paris, 75970
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg, 67085
    France

    Site Not Available

  • empty

    Fulda, 36043
    Germany

    Site Not Available

  • KRH Klinikum Siloah-Oststadt-Heidehaus

    Hannover, 30459
    Germany

    Site Not Available

  • empty

    München-Gauting, 82131
    Germany

    Site Not Available

  • empty

    Oldenburg, 26121
    Germany

    Site Not Available

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098
    Germany

    Site Not Available

  • Attikon University General Hospital

    Athens, 12464
    Greece

    Site Not Available

  • Sotiria Chest Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • empty

    Patras, 26500
    Greece

    Site Not Available

  • empty

    Thermi, Thessaloniki, 57001
    Greece

    Site Not Available

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22
    Greece

    Site Not Available

  • Georgios Papanikolaou General Hosp. of Thessaloniki

    Thessaloniki, 57010
    Greece

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Uzsoki Utcai Korhaz

    Budapest, 1145
    Hungary

    Site Not Available

  • empty

    Deszk, 6772
    Hungary

    Site Not Available

  • empty

    Gyor, 9024
    Hungary

    Site Not Available

  • Matrai Gyogyintezet

    Matrahaza, 3233
    Hungary

    Site Not Available

  • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • University of Pecs, I st Dept of Internal Medicine

    Pecs, 7624
    Hungary

    Site Not Available

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

    Szolnok, 5000
    Hungary

    Site Not Available

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna 47014
    Italy

    Site Not Available

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna 47900
    Italy

    Site Not Available

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli-Venezia Giulia 33081
    Italy

    Site Not Available

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardia 24100
    Italy

    Site Not Available

  • Azienda Ospedaliera Istituti Ospitalieri

    Cremona, Lombardia 26100
    Italy

    Site Not Available

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l.

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Asst Di Monza

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • empty

    Monza Mi, Lombardia 22052
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardia 20089
    Italy

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • empty

    Padova, Veneto 35128
    Italy

    Site Not Available

  • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

    Verona, Veneto 37126
    Italy

    Site Not Available

  • empty

    Gwangju, 501-757
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

    Site Not Available

  • empty

    Seongnam-si, 463-707
    Korea, Republic of

    Site Not Available

  • empty

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon-si,, 442-723
    Korea, Republic of

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Site Not Available

  • empty

    Otwock, 05-400
    Poland

    Site Not Available

  • empty

    Poznan, 60-693
    Poland

    Site Not Available

  • empty

    Szczecin, 70-891
    Poland

    Site Not Available

  • County Hospital Alba; Oncology

    Alba Iulia, 510073
    Romania

    Site Not Available

  • Dr Constantin Opris Emergency County Hospital Baia Mare

    Baia Mare, 430031
    Romania

    Site Not Available

  • Teo Health SA - Saint Constantin Hospital

    Brasov, 500091
    Romania

    Site Not Available

  • Oncology Center Sf. Nectarie

    Craiova, 200347
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie

    Iasi, 700483
    Romania

    Site Not Available

  • Sibiu Emergency Clinical County Hospital

    Sibiu, 550245
    Romania

    Site Not Available

  • empty

    Targu-Mures, 540136
    Romania

    Site Not Available

  • Oncomed SRL

    Timisoara, 300239
    Romania

    Site Not Available

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • empty

    Ivanovo, 153040
    Russian Federation

    Site Not Available

  • Kursk Regional Clinical Oncology Dispensary

    Kursk, 305035
    Russian Federation

    Site Not Available

  • empty

    Moscow, 105229
    Russian Federation

    Site Not Available

  • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

    Nizhny Novgorod, 603081
    Russian Federation

    Site Not Available

  • empty

    Ryazan, 390046
    Russian Federation

    Site Not Available

  • empty

    Saint Petersburg, 197758
    Russian Federation

    Site Not Available

  • Mordovia State University

    Saransk, 430032
    Russian Federation

    Site Not Available

  • Leningrad Regional Clinical Hospital

    St Petersburg, 194291
    Russian Federation

    Site Not Available

  • empty

    St. Petersburg, 197758
    Russian Federation

    Site Not Available

  • Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clin Hospital Center - Kragujevac; Pulmonary Diseases

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Institute of Lung Diseases Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Barcelona, 08916
    Spain

    Site Not Available

  • Fundacion Investigacion Hospital La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • empty

    Hat Yai, 90110
    Thailand

    Site Not Available

  • empty

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • empty

    Muang, 57000
    Thailand

    Site Not Available

  • empty

    Phitsanulok, 65000
    Thailand

    Site Not Available

  • empty

    Adana, 1330
    Turkey

    Site Not Available

  • empty

    Ankara, 06100
    Turkey

    Site Not Available

  • empty

    Istanbul, 34000
    Turkey

    Site Not Available

  • empty

    Izmir, 35110
    Turkey

    Site Not Available

  • empty

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Diana Princess of Wales Hosp.

    Grimsby, DN33 2BA
    United Kingdom

    Site Not Available

  • Sarah Cannon Research Institute

    London, W1G 6AD
    United Kingdom

    Site Not Available

  • Christie Hospital NHS Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • empty

    Binghamton, Alabama 35233
    United States

    Site Not Available

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California 92008
    United States

    Site Not Available

  • Marin Cancer Care Inc

    Greenbrae, California 94904
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • empty

    Los Angeles, California 90048
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • empty

    Sepulveda, California 91343
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • empty

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • empty

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Straub Clinic & Hospital; Oncology

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • empty

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Ingalls Memorial Hospital

    Harvey, Illinois 60426
    United States

    Site Not Available

  • Consultants in Blood Disorders & Cancer

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Bay Hematology Oncology

    Easton, Maryland 21601
    United States

    Site Not Available

  • empty

    Jackson, Michigan 49201
    United States

    Site Not Available

  • Montana Cancer Specialists

    Missoula, Montana 59802
    United States

    Site Not Available

  • Atlantic Health Cancer Center

    Summit, New Jersey 07902
    United States

    Site Not Available

  • Atlantic Health Cancer Center

    Summitt, New Jersey 07902
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • Presbyterian Hospital

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • First Health of the Carolinas

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • empty

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • empty

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Wellmont Cancer Institute

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • University Oncology Associates

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Sarah Cannon Cancer Center

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • empty

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Vanderbilt Medical Center

    Nashville, Tennessee 37232-7610
    United States

    Site Not Available

  • empty

    Houston, Texas 77030
    United States

    Site Not Available

  • empty

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington 98002-4117
    United States

    Site Not Available

  • empty

    Bremerton, Washington 98310
    United States

    Site Not Available

  • empty

    Seattle, Washington 98122
    United States

    Site Not Available

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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