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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02409355
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Histologically or cytologically confirmed Stage IV squamous NSCLC
- 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
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine + Cisplatin/Carboplatin Gemcitabine 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. Gemcitabine + Cisplatin/Carboplatin 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. Atezolizumab Atezolizumab Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit. Gemcitabine + Cisplatin/Carboplatin Cisplatin 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (82)
University of Maryland
🇺🇸Baltimore, Maryland, United States
California Cancer Associates for Research & Excellence, Inc.
🇺🇸Encinitas, California, United States
Marin Cancer Care Inc
🇺🇸Greenbrae, California, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
🇺🇸Norwich, Connecticut, 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
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Bay Hematology Oncology
🇺🇸Easton, Maryland, United States
Atlantic Health Cancer Center
🇺🇸Summit, New Jersey, United States
Maimonides Medical Center
🇺🇸Brooklyn, 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
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University Oncology Associates
🇺🇸Chattanooga, Tennessee, United States
Wellmont Cancer Institute
🇺🇸Bristol, Tennessee, United States
Multiscan s.r.o.
🇨🇿Pardubice, Czechia
MultiCare Regional Cancer Center - Auburn
🇺🇸Auburn, Washington, United States
Brüderkrankenhaus St. Josef Paderborn
🇩🇪Paderborn, Germany
Centre Paul Strauss
🇫🇷Strasbourg, France
Hopital Tenon; Oncologie Radiotherapie
🇫🇷Paris, France
Attikon University General Hospital
🇬🇷Athens, Greece
KRH Klinikum Siloah-Oststadt-Heidehaus
🇩🇪Hannover, Germany
Sotiria Chest Hospital of Athens
🇬🇷Athens, Greece
Bioclinic Thessaloniki
🇬🇷Thessaloniki, Greece
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Georgios Papanikolaou General Hosp. of Thessaloniki
🇬🇷Thessaloniki, Greece
Uzsoki Utcai Korhaz
ðŸ‡ðŸ‡ºBudapest, Hungary
Matrai Gyogyintezet
ðŸ‡ðŸ‡ºMatrahaza, Hungary
University of Pecs, I st Dept of Internal Medicine
ðŸ‡ðŸ‡ºPecs, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
ðŸ‡ðŸ‡ºSzolnok, Hungary
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
🇮🇹Verona, Veneto, Italy
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Suwon-si,, Korea, Republic of
Sibiu Emergency Clinical County Hospital
🇷🇴Sibiu, Romania
Oncomed SRL
🇷🇴Timisoara, Romania
Mordovia State University
🇷🇺Saransk, Russian Federation
Clin Hospital Center - Kragujevac; Pulmonary Diseases
🇷🇸Kragujevac, Serbia
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
🇪🇸Badalona, Barcelona, Spain
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
Diana Princess of Wales Hosp.
🇬🇧Grimsby, United Kingdom
Fundacion Investigacion Hospital La Fe de Valencia
🇪🇸Valencia, Spain
Hosp Clinico Univ Lozano Blesa
🇪🇸Zaragoza, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, United Kingdom
Straub Clinic & Hospital; Oncology
🇺🇸Honolulu, Hawaii, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Irccs Centro Di Riferimento Oncologico (CRO)
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Asst Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
Azienda Ospedaliera Istituti Ospitalieri
🇮🇹Cremona, Lombardia, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
🇮🇹Milano, Lombardia, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Asst Di Monza
🇮🇹Monza, Lombardia, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Lombardia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Piemonte, Italy
Hôpital du Cluzeau
🇫🇷Limoges, France
Teo Health SA - Saint Constantin Hospital
🇷🇴Brasov, Romania
Oncology Center Sf. Nectarie
🇷🇴Craiova, Romania
Leningrad Regional Clinical Hospital
🇷🇺St Petersburg, Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
🇷🇺Arkhangelsk, Russian Federation
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
🇷🇺Nizhny Novgorod, Russian Federation
Sarah Cannon Cancer Center
🇺🇸Germantown, Tennessee, United States
Dr Constantin Opris Emergency County Hospital Baia Mare
🇷🇴Baia Mare, Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
🇷🇴Iasi, Romania
Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
🇷🇸Belgrade, Serbia
Institute of Lung Diseases Vojvodina
🇷🇸Sremska Kamenica, Serbia
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
County Hospital Alba; Oncology
🇷🇴Alba Iulia, Romania
Kursk Regional Clinical Oncology Dispensary
🇷🇺Kursk, Russian Federation
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Consultants in Blood Disorders & Cancer
🇺🇸Louisville, Kentucky, United States
Ospedale Infermi di Rimini
🇮🇹Rimini, Emilia-Romagna, Italy
Montefiore Medical Center
🇺🇸Bronx, New York, United States