Lung Cancer Clinical Trial

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator’s Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

Summary

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
PD-L1+ on immunohistochemistry testing performed by central lab
Men and women, ages ≥ 18 years of age

Exclusion Criteria:

Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
Known anaplastic lymphoma kinase (ALK) translocations
Untreated central nervous system (CNS) metastases
Previous malignancies
Active, known or suspected autoimmune disease

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1325

Study ID:

NCT02041533

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 138 Locations for this study

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Southern Cancer Center, Inc.
Mobile Alabama, 36608, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson Arizona, 85704, United States
Stanford Cancer Institute
Stanford California, 94305, United States
University Of Colorado Hosp
Aurora Colorado, 80045, United States
Yale University
New Haven Connecticut, 06520, United States
Baptist Health Medical Group Oncology
Miami Florida, 33176, United States
Ocala Oncology Center
Ocala Florida, 34471, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Local Institution - 0010
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Center, P.C.
Marietta Georgia, 30060, United States
Rush University Med Ctr
Chicago Illinois, 60612, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Crescent City Research Consortium, LLC
Marrero Louisiana, 70072, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center.
Boston Massachusetts, 02215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
New York University Clinical Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University Of North Carolina At Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University
Durham North Carolina, 27710, United States
University Hospitals
Cleveland Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States
University Of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0011
Charleston South Carolina, 29425, United States
Local Institution - 0038
Greenville South Carolina, 29601, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University Of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Univ Of Tx. Md Anderson
Houston Texas, 77030, United States
Cancer Centers of South Texas
San Antonio Texas, 78212, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, 98902, United States
COIBA
Berazategui Buenos Aires, 1880, Argentina
Instituto Medico Especializado Alexander Fleming
Capital Federal Buenos Aires, 1426, Argentina
Local Institution - 0052
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Clinica Colombo
Cordoba , 5000, Argentina
Instituto Oncologico De Cordoba
Cordoba , 5000, Argentina
Local Institution
Camperdown New South Wales, 2050, Australia
Local Institution
Brisbane Queensland, 4102, Australia
Local Institution
Elizabeth Vale South Australia, 5112, Australia
Local Institution
Fitzroy Victoria, 3065, Australia
Local Institution
Heidelberg Victoria, 3084, Australia
Local Institution
Wels , 4600, Austria
Local Institution
Wien , 1090, Austria
Local Institution
Brussels , 1090, Belgium
Local Institution
Edegem , 2650, Belgium
Local Institution
Gent , 9000, Belgium
Local Institution
Leuven , 3000, Belgium
Local Institution - 0134
Ijui Rio Grande Do Sul, 98700, Brazil
Local Institution
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Local Institution
Barretos Sao Paulo, 14780, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Hospitalier De L'Universite De Montreal
Montreal Quebec, H2X 3, Canada
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
Local Institution
Olomouc , 779 0, Czechia
Local Institution
Ostrava - Poruba , 708 5, Czechia
Local Institution
Praha 8 , 180 8, Czechia
Local Institution
Usti nad Labem , 401 1, Czechia
Local Institution - 0120
Helsinki , 00029, Finland
Local Institution - 0119
Tampere , 33521, Finland
Local Institution - 0118
Vaasa , 65130, Finland
Hopital Cote De Nacre C H U Caen
Caen , 14000, France
Local Institution
Lille , 59000, France
Local Institution
Marseille Cedex 20 , 13915, France
Local Institution
Pontoise Cedex , 95303, France
Local Institution
Rennes Cedex 9 , 35033, France
Local Institution
Strasbourg , 67090, France
Sozialstiftung Bamberg
Bamberg , 96049, Germany
LungenClinic Grosshansdorf GmbH
Grosshansdorf , 22927, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg , 69126, Germany
Local Institution
Koeln , 50937, Germany
Klinik Schillerhoehe GmbH
Stuttgart , 70376, Germany
Local Institution
Wiesbaden , 65199, Germany
Local Institution - 0073
Heraklion Creta, 71110, Greece
Sotiria General Hospital
Athens , 11527, Greece
Local Institution
Budapest , 1121, Hungary
Local Institution
Debrecen , 4032, Hungary
Local Institution
Matrahaza , 3233, Hungary
Azienda Ospedaliera Moscati
Avellino , 83100, Italy
Local Institution
Livorno , 57100, Italy
Local Institution - 0143
Milano , 20141, Italy
Local Institution - 0142
Napoli , 80131, Italy
Local Institution
Perugia , 06132, Italy
Local Institution
Terni , 05100, Italy
Local Institution
Nagoya Aichi, 46000, Japan
Local Institution
Nagoya Aichi, 46486, Japan
Local Institution
Matsuyama-shi Ehime, 79102, Japan
Local Institution
Kobe City Hyogo, 65000, Japan
Local Institution
Natori-shi Miyagi, 98112, Japan
Local Institution - 0151
Niigata-shi Niigata, 951-8, Japan
Local Institution
Habikino-city Osaka, 58385, Japan
Local Institution
Miyakojima-ku Osaka, 534-0, Japan
Local Institution
Osaka-sayama Osaka, 589-8, Japan
Local Institution
Sakai-shi Osaka, 591-8, Japan
Local Institution
Kitaadachi-gun Saitama, 36208, Japan
Local Institution
Sunto-gun Shizuoka, 41187, Japan
Local Institution
Chuo-ku Tokyo, 10400, Japan
Local Institution
Akashi, Hyogo , 673-8, Japan
Local Institution
Ota, Gunma , 37385, Japan
Local Institution
Sapporo, Hokkaido , 062-0, Japan
Local Institution
Tokyo , 13585, Japan
Local Institution
Wakayama , 641-8, Japan
Local Institution
Seoul , 03722, Korea, Republic of
Local Institution
Seoul , 135-7, Korea, Republic of
Local Institution
Seoul , , Korea, Republic of
Local Institution - 0117
Mexico Distrito Federal, 14080, Mexico
Local Institution
Guadalajara Jalisco, 44280, Mexico
Local Institution
Merida Yucatan, 97133, Mexico
Local Institution
Amsterdam , 1066 , Netherlands
Local Institution
Groningen , 9713 , Netherlands
Local Institution
Rotterdam , 3014 , Netherlands
Local Institution
Bydgoszcz , 85-79, Poland
Local Institution
Krakow , 31-20, Poland
Local Institution
Lodz , 93-51, Poland
Local Institution
Warszawa , 02-78, Poland
Local Institution
Wodzislaw Slaski , 44-30, Poland
Local Institution - 0068
Cluj Napoca , 40001, Romania
Local Institution
Cluj-napoca , 40035, Romania
Local Institution
Ploiesti , 10033, Romania
Local Institution
Barcelona , 08035, Spain
Local Institution - 0041
Las Palmas De Gran Canaria , 35016, Spain
Local Institution
Madrid , 28050, Spain
Local Institution
Malaga , 29010, Spain
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Sevilla , 41013, Spain
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Valencia , 46014, Spain
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Stockholm , 171 7, Sweden
Local Institution - 0125
Uppsala , 751 8, Sweden
Local Institution
Chur , 7000, Switzerland
Local Institution
Lausanne , 1011, Switzerland
Local Institution
Zuerich , 8091, Switzerland
Local Institution
Taipei , 11217, Taiwan
Local Institution
Kayseri , 38039, Turkey
Local Institution - 0098
London Greater London, N18 1, United Kingdom
Local Institution
Manchester Greater Manchester, M20 4, United Kingdom
Local Institution
Leeds Yorkshire, LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1325

Study ID:

NCT02041533

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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