Lung Cancer Clinical Trial

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)

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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

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 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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

8

Study ID:

NCT02409355

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 80 Locations for this study

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California Cancer Associates for Research & Excellence, Inc.
Encinitas California, 92008, United States
Marin Cancer Care Inc
Greenbrae California, 94904, United States
University of California San Diego
La Jolla California, 92093, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange California, 92868, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich Connecticut, 06360, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Florida Hospital
Orlando Florida, 32803, United States
Straub Clinic & Hospital; Oncology
Honolulu Hawaii, 96813, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Consultants in Blood Disorders & Cancer
Louisville Kentucky, 40207, United States
University of Maryland
Baltimore Maryland, 21201, United States
Bay Hematology Oncology
Easton Maryland, 21601, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Atlantic Health Cancer Center
Summit New Jersey, 07902, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Maimonides Medical Center
Brooklyn New York, 11219, United States
Presbyterian Hospital
Charlotte North Carolina, 28204, United States
Carolina Oncology Specialists, PA - Hickory
Hickory North Carolina, 28602, United States
First Health of the Carolinas
Pinehurst North Carolina, 28374, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Wellmont Cancer Institute
Bristol Tennessee, 37620, United States
University Oncology Associates
Chattanooga Tennessee, 37403, United States
Sarah Cannon Cancer Center
Germantown Tennessee, 38138, United States
Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
MultiCare Regional Cancer Center - Auburn
Auburn Washington, 98002, United States
West Virginia University Hospital
Morgantown West Virginia, 26506, United States
Multiscan s.r.o.
Pardubice , 532 0, Czechia
Hôpital du Cluzeau
Limoges , 87042, France
Hopital Tenon; Oncologie Radiotherapie
Paris , 75970, France
Centre Paul Strauss
Strasbourg , 67085, France
KRH Klinikum Siloah-Oststadt-Heidehaus
Hannover , 30459, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn , 33098, Germany
Sotiria Chest Hospital of Athens
Athens , 11527, Greece
Attikon University General Hospital
Athens , 12464, Greece
Bioclinic Thessaloniki
Thessaloniki , 546 2, Greece
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki , 57010, Greece
Semmelweis Egyetem
Budapest , 1083, Hungary
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Matrai Gyogyintezet
Matrahaza , 3233, Hungary
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
University of Pecs, I st Dept of Internal Medicine
Pecs , 7624, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok , 5000, Hungary
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Ospedale Infermi di Rimini
Rimini Emilia-Romagna, 47900, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano Friuli-Venezia Giulia, 33081, Italy
Asst Papa Giovanni XXIII
Bergamo Lombardia, 24100, Italy
Azienda Ospedaliera Istituti Ospitalieri
Cremona Lombardia, 26100, Italy
Ospedale San Raffaele S.r.l.
Milano Lombardia, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Asst Di Monza
Monza Lombardia, 20900, Italy
Istituto Clinico Humanitas
Rozzano (MI) Lombardia, 20089, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino Piemonte, 10126, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona Veneto, 37126, Italy
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
Suwon-si, , 442-7, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
County Hospital Alba; Oncology
Alba Iulia , 51007, Romania
Dr Constantin Opris Emergency County Hospital Baia Mare
Baia Mare , 43003, Romania
Teo Health SA - Saint Constantin Hospital
Brasov , 50009, Romania
Oncology Center Sf. Nectarie
Craiova , 20034, Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi , 70048, Romania
Sibiu Emergency Clinical County Hospital
Sibiu , 55024, Romania
Oncomed SRL
Timisoara , 30023, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk , 16304, Russian Federation
Kursk Regional Clinical Oncology Dispensary
Kursk , 30503, Russian Federation
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod , 60308, Russian Federation
Mordovia State University
Saransk , 43003, Russian Federation
Leningrad Regional Clinical Hospital
St Petersburg , 19429, Russian Federation
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade , 11000, Serbia
Clin Hospital Center - Kragujevac; Pulmonary Diseases
Kragujevac , 34000, Serbia
Institute of Lung Diseases Vojvodina
Sremska Kamenica , 21204, Serbia
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Fundacion Investigacion Hospital La Fe de Valencia
Valencia , 46026, Spain
Hosp Clinico Univ Lozano Blesa
Zaragoza , 50009, Spain
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Diana Princess of Wales Hosp.
Grimsby , DN33 , United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

8

Study ID:

NCT02409355

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

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