Lung Cancer Clinical Trial

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

Summary

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

View Eligibility Criteria

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

719

Study ID:

NCT03215706

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 114 Locations for this study

See Locations Near You

Memorial Health Systems
Colorado Springs Colorado, 80909, United States
Cancer Center Of Central Connecticut
Plainville Connecticut, 06062, United States
Baptist Md Anderson Cancer Center
Jacksonville Florida, 32207, United States
Northwest Georgia Oncology Center, P.C.
Marietta Georgia, 30060, United States
Cancer Center Of Kansas
Wichita Kansas, 67214, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Broome Oncology
Johnson City New York, 13790, United States
Winthrop University Hospital
Mineola New York, 11501, United States
The Ohio State University
Columbus Ohio, 43210, United States
West Penn Hospital
Jefferson Hills Pennsylvania, 15025, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15213, United States
Charleston Hematology Oncology Associates, Pa
Charleston South Carolina, 29414, United States
Southwest Regional Cancer Clinic
Saint George Utah, 84770, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States
Instituto Alexander Fleming
Caba Buenos Aires, 1426, Argentina
Local Institution - 0028
Rio Cuarto Cordoba, 5800, Argentina
Clinica Viedma S.A.
Viedma RIO Negro, 8500, Argentina
Sanatorio Parque
Rosario Santa FE, 2000, Argentina
Local Institution - 0030
Cordoba , 5000, Argentina
Local Institution
Gosford New South Wales, 2250, Australia
Local Institution
Bedford Park South Australia, 5042, Australia
Local Institution
Box Hill Victoria, 3128, Australia
Local Institution
Heidelberg Victoria, 3084, Australia
St John of God Murdoch Hospital
Murdoch Western Australia, 6150, Australia
Local Institution
Charleroi , 6000, Belgium
Local Institution
Leuven , 3000, Belgium
Local Institution
Roeselare , 8800, Belgium
Local Institution
Natal RIO Grande DO Norte, 59075, Brazil
Local Institution
Ijui Rio Grande Do Sul, 98700, Brazil
Local Institution
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution
Blumenau Santa Catarina, 89010, Brazil
Local Institution
Barretos Sao Paulo, 14780, Brazil
Local Institution
Sao Jose De Rio Preto Sao Paulo, 15091, Brazil
Local Institution
Rio De Janeiro , 20231, Brazil
Local Institution
Sao Paulo , 01323, Brazil
Local Institution
Montreal Quebec, H1T 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Mcgill University Health Center - Royal Victoria Hospital
Montreal Quebec, H4A 3, Canada
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
Bradfordhill
Santiago de Chile Metropolitana, , Chile
Fundacion Arturo Lopez Perez
Santiago Metropolitana, , Chile
Hospital Clinico Vina Del Mar
Vina Del Mar Valparaiso, 25206, Chile
Local Institution
Beijing Beijing, 10003, China
Local Institution
Haikou Hainan, 57031, China
Local Institution
Zhengzhou Henan, 45000, China
Local Institution
Zhengzhou Henan, 45005, China
Local Institution
Changsha Hunan, 41000, China
Local Institution
Changchun Jilin, 13001, China
Local Institution
Xian Shan3xi, 71003, China
Local Institution
Shanghai Shanghai, 20003, China
Local Institution
Hangzhou Zhejiang, 31001, China
Local Institution
Hangzhou Zhejiang, 31002, China
Local Institution
Beijing , 10220, China
Local Institution
Caen , 14000, France
Local Institution
Lille Cedex , 59037, France
Centre Leon Berard
Lyon Cedex 08 , 69373, France
Local Institution
Montpellier , 34295, France
Local Institution - 0035
Nantes , 44093, France
Local Institution
Paris , 75970, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Centre Hospitalier De Saint-Brieuc Hopital Yves Le Foll
Saint-Brieuc , 22027, France
Local Institution
Berlin , 14165, Germany
Local Institution - 0016
Gauting , 82131, Germany
LungenClinic Grosshansdorf GmbH
Grosshansdorf , 22927, Germany
Local Institution - 0019
Hemer , 58675, Germany
Lungenfachklinik Immenhausen
Immenhausen , 34376, Germany
Universitaetsklinikum Magdeburg
Magdeburg , 39120, Germany
Muenchen Klinik - Bogenhausen
Muenchen , 81925, Germany
Klinik Schillerhoehe GmbH
Stuttgart , 70376, Germany
Local Institution
Dublin , 8, Ireland
Local Institution
Limerick , V94 F, Ireland
Ospedale San Luca
Lucca , 55100, Italy
Irccs Ospedale S. Raffaele
Milano , 20132, Italy
Azienda Ospedaliera Monaldi
Napol , 80131, Italy
Local Institution
Fukushima-shi Fukushima, 96012, Japan
Local Institution
Maebashi-shi Gunma, 37185, Japan
Local Institution
Ota-shi Gunma, 37385, Japan
Local Institution
Hiroshima-shi Hiroshima, 73085, Japan
Local Institution
Hiroshima-shi Hiroshima, 73485, Japan
Local Institution
Sapporo-shi Hokkaido, 06086, Japan
Local Institution
Akashi-shi Hyogo, 67385, Japan
Local Institution
Himeji-shi Hyogo, 67085, Japan
Local Institution
Kobe-shi Hyogo, 65000, Japan
Local Institution
Kanazawa-shi Ishikawa, 92086, Japan
Local Institution
Shiwa-gun Iwate, 02836, Japan
Local Institution
Yokohama-shi Kanagawa, 22108, Japan
Local Institution
Yokohama-Shi Kanagawa, 23600, Japan
Local Institution
Yokohama-shi Kanagawa, 24185, Japan
Local Institution
Niigata-shi Niigata, 95185, Japan
Local Institution
Okayama-shi Okayama, 70085, Japan
Local Institution
Habikino-shi Osaka, 58385, Japan
Local Institution
Osaka-sayama-shi Osaka, 58985, Japan
Local Institution
Osaka-shi Osaka, 54585, Japan
Local Institution
Kitaadachi-gun Saitama, 36208, Japan
Local Institution
Ube-shi Yamaguchi, 75502, Japan
Oncotech
La Paz BAJA Californa SUR, 23040, Mexico
Local Institution
Guadalajara Jalisco, 44280, Mexico
Faicic S. de Rl. de Cv
Veracruz, Veracruz , 91900, Mexico
Ambulatorium Chemioterapii
Bydgoszcz , 85-79, Poland
Oddzial Onkologii
Bytom , 41-90, Poland
Local Institution
Gdansk , 80-21, Poland
Local Institution - 0034
Bucharest , 02012, Romania
Local Institution - 0031
Cluj Napoca , 40001, Romania
Local Institution
Craiova , 20034, Romania
Local Institution
Moscow , 11547, Russian Federation
Local Institution
St.petersburg , 19775, Russian Federation
Comp. Hosp. Univ. A Coruna
A Coruña , 15006, Spain
H. Univ. Vall dHebron
Barcelona , 08035, Spain
Local Institution - 0052
Madrid , 28041, Spain
Local Institution - 0055
Malaga , 29010, Spain
Hospital Universitario La Fe
Valencia , 46026, Spain
Local Institution
Guildford , GU2 7, United Kingdom
Local Institution
London , SE1 9, United Kingdom
Local Institution
Tauton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

719

Study ID:

NCT03215706

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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