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)
NCT ID: NCT02409355
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2015-05-07
2017-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m\^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Gemcitabine
Gemcitabine will be administered at 1000 mg/m\^2 (when coadministered with carboplatin) or 1250 mg/m\^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
Interventions
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Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m\^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Gemcitabine
Gemcitabine will be administered at 1000 mg/m\^2 (when coadministered with carboplatin) or 1250 mg/m\^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* 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 Criteria
* 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 metastasis or death
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab formulation or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
* 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 4 weeks prior to randomization
* Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
* Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
Marin Cancer Care Inc
Greenbrae, California, United States
University of California San Diego
La Jolla, California, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange, California, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital
Orlando, Florida, United States
Straub Clinic & Hospital; Oncology
Honolulu, Hawaii, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Consultants in Blood Disorders & Cancer
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Bay Hematology Oncology
Easton, Maryland, United States
Montana Cancer Specialists
Missoula, Montana, United States
Atlantic Health Cancer Center
Summit, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States
First Health of the Carolinas
Pinehurst, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Wellmont Cancer Institute
Bristol, Tennessee, United States
University Oncology Associates
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center
Germantown, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Multiscan s.r.o.
Pardubice, , Czechia
Hôpital du Cluzeau
Limoges, , France
Hopital Tenon; Oncologie Radiotherapie
Paris, , France
Centre Paul Strauss
Strasbourg, , France
KRH Klinikum Siloah-Oststadt-Heidehaus
Hanover, , Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, , Germany
Sotiria Chest Hospital of Athens
Athens, , Greece
Attikon University General Hospital
Athens, , Greece
Bioclinic Thessaloniki
Thessaloniki, , Greece
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Matrai Gyogyintezet
Mátraháza, , Hungary
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
University of Pecs, I st Dept of Internal Medicine
Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, , Hungary
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardy, Italy
Ospedale San Raffaele S.r.l.
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Asst Di Monza
Monza, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona, Veneto, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
County Hospital Alba; Oncology
Alba Iulia, , Romania
Dr Constantin Opris Emergency County Hospital Baia Mare
Baia Mare, , Romania
Teo Health SA - Saint Constantin Hospital
Brasov, , Romania
Oncology Center Sf. Nectarie
Craiova, , Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iași, , Romania
Sibiu Emergency Clinical County Hospital
Sibiu, , Romania
Oncomed SRL
Timișoara, , Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, , Russia
Kursk Regional Clinical Oncology Dispensary
Kursk, , Russia
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Mordovia State University
Saransk, , Russia
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, , Serbia
Institute of Lung Diseases Vojvodina
Kamenitz, , Serbia
Clin Hospital Center - Kragujevac; Pulmonary Diseases
Kragujevac, , Serbia
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Fundacion Investigacion Hospital La Fe de Valencia
Valencia, , Spain
Hosp Clinico Univ Lozano Blesa
Zaragoza, , Spain
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Diana Princess of Wales Hosp.
Grimsby, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-003106-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29432
Identifier Type: -
Identifier Source: org_study_id
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