Lung Cancer Clinical Trial

A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

Summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib).
No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy.
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC). For participants who were treated with osimertinib, T790M testing is not required.
Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period 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 randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
Eastern Cooperative Group (ECOG) Performance Status 0-1
Life expectancy is at least 3 months

Exclusion Criteria:

Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
Carcinomatous meningitis
Active, known or suspected autoimmune disease are excluded
ALK translocation
Known SCLC transformation
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

274

Study ID:

NCT02864251

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 103 Locations for this study

See Locations Near You

Pacific Shores Medical Group
Long Beach California, 90808, United States
Local Institution - 0029
Los Angeles California, 90017, United States
UCLA Cancer Hematology Oncology
Los Angeles California, 90095, United States
Local Institution - 0061
Orange California, 92868, United States
Torrance Memorial Physican Network
Redondo Beach California, 90277, United States
Yale University School of Medicine
New Haven Connecticut, 06520, United States
University of Chicago
Chicago Illinois, 60637, United States
Johns Hopkins University
Baltimore Maryland, 21205, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
NYU Langone Medical Center
New York New York, 10016, United States
Duke University Medical Center
Butner North Carolina, 27509, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Texas Health Physicians Group
Arlington Texas, 76012, United States
Baylor Scott and White Research Institute
Temple Texas, 76508, United States
Tyler Hematology/Oncology PA
Tyler Texas, 75701, United States
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City Utah, 84112, United States
Local Institution - 0168
Montreal Quebec, H4A3J, Canada
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Beijing Beijing, 10073, China
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Beijing Beijing, 10085, China
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Chongqing Chongqing, 40004, China
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Guangzhou Guangdong, 51000, China
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Zhengzhou Henan, 45000, China
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Hong Kong Hong Kong, , China
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Changsha Hunan, 41001, China
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Changchun Jilin, 13001, China
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Changchun Jilin, 13002, China
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Xian Shan3xi, 71003, China
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Shanghai Shanghai, 20002, China
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Shanghai Shanghai, 20003, China
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Chengdu Sichuan, 61004, China
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Hangzhou Zhejiang, 31000, China
Local Institution - 0017
Hangzhou Zhejiang, 31001, China
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Hangzhou Zhejiang, 31001, China
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Marseille , 13915, France
Local Institution - 0156
Paris , 75005, France
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Rennes , 35033, France
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Toulouse cedex 9 , 31059, France
Local Institution - 0027
Hong Kong , 0, Hong Kong
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Hong Kong , , Hong Kong
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Shatin , , Hong Kong
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Nagoya-shi Aichi, 46486, Japan
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Hirosaki-shi Aomori, 036-8, Japan
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Matsuyama Ehime, 791-0, Japan
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Iizuka Fukuoka, 82085, Japan
Local Institution - 0059
Kurume Fukuoka, 830-0, Japan
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Fukushima-shi Fukushima, 96012, Japan
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Koriyama Fukushima, 96301, Japan
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Fukuyama Hiroshima, 72109, Japan
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Hiroshima-Shi Hiroshima, 73485, Japan
Local Institution - 0070
Sapporo Hokkaido, 003-0, Japan
Local Institution
Himeji-shi Hyogo, 67085, Japan
Local Institution - 0097
Itami Hyogo, 66485, Japan
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Kobe City Hyogo, 65000, Japan
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Kobe Hyogo, 65000, Japan
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Bunkyo-ku Kanagawa, 11386, Japan
Local Institution - 0081
Yokohama-shi Kanagawa, 22108, Japan
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Yokohama Kanagawa, 236-0, Japan
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Yokohama Kanagawa, 241-8, Japan
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Kumamoto-shi Kumamoto, 861-4, Japan
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Natori-shi Miyagi, 981-1, Japan
Local Institution - 0077
Sendai-shi Miyagi, 98008, Japan
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Hirakata-shi Osaka, 573-1, Japan
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Kishiwada shi Osaka, 59685, Japan
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Osaka-Sayama Osaka, 589-8, Japan
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Sakai Osaka, 591-8, Japan
Local Institution - 0076
Hidaka Saitama, 350-1, Japan
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Kitaadachi-gun Saitama, 362-0, Japan
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Chuo Tokyo, 104-0, Japan
Local Institution - 0078
Koto Tokyo, 135-8, Japan
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Ube Shi Yamaguchi, 75502, Japan
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Chiba , 26086, Japan
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Fukuoka , 810-0, Japan
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Fukuoka , 812-8, Japan
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Niigata , 990-9, Japan
Local Institution - 0079
Tokyo , 16000, Japan
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Toyama , 930-8, Japan
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Wakayama , 64185, Japan
Local Institution - 0037
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Local Institution - 0035
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Local Institution
Cheogju-si , 361-7, Korea, Republic of
Local Institution
Gyeonggi-do, , 10408, Korea, Republic of
Local Institution - 0036
Gyeonggi-do , 463-7, Korea, Republic of
Local Institution
Inchoen , 405-7, Korea, Republic of
Local Institution - 0038
Seoul , 03722, Korea, Republic of
Local Institution
Seoul , 06591, Korea, Republic of
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Singapore , 11907, Singapore
Local Institution - 0041
Singapore , 30843, Singapore
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Barcelona , 08035, Spain
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Hospitalet de Llobregat , 08907, Spain
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Madrid , 28041, Spain
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Majadahonda , 28222, Spain
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Malaga , 29010, Spain
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Zaragoza , 50009, Spain
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Chiayi , 62247, Taiwan
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Kaohsiung City , 807, Taiwan
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Kaohsiung city , 82445, Taiwan
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Kaohsiung , 833, Taiwan
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Taichung , 404, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 704, Taiwan
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Tainan , 736, Taiwan
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Taipei City , 114, Taiwan
Local Institution
Taipei , 10002, Taiwan
Local Institution - 0066
Taipei , 10449, Taiwan
Local Institution - 0108
Taipei , 11031, Taiwan
Local Institution - 0023
Taipei , 112, Taiwan
Local Institution
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

274

Study ID:

NCT02864251

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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