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.
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
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There are 103 Locations for this study
Long Beach California, 90808, United States
Los Angeles California, 90017, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Redondo Beach California, 90277, United States
New Haven Connecticut, 06520, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
New York New York, 10016, United States
Butner North Carolina, 27509, United States
Philadelphia Pennsylvania, 19111, United States
Arlington Texas, 76012, United States
Temple Texas, 76508, United States
Tyler Texas, 75701, United States
Salt Lake City Utah, 84112, United States
Montreal Quebec, H4A3J, Canada
Beijing Beijing, 10073, China
Beijing Beijing, 10085, China
Chongqing Chongqing, 40004, China
Guangzhou Guangdong, 51000, China
Zhengzhou Henan, 45000, China
Hong Kong Hong Kong, , China
Changsha Hunan, 41001, China
Changchun Jilin, 13001, China
Changchun Jilin, 13002, China
Xian Shan3xi, 71003, China
Shanghai Shanghai, 20002, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31001, China
Marseille , 13915, France
Paris , 75005, France
Rennes , 35033, France
Toulouse cedex 9 , 31059, France
Hong Kong , 0, Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Nagoya-shi Aichi, 46486, Japan
Hirosaki-shi Aomori, 036-8, Japan
Matsuyama Ehime, 791-0, Japan
Iizuka Fukuoka, 82085, Japan
Kurume Fukuoka, 830-0, Japan
Fukushima-shi Fukushima, 96012, Japan
Koriyama Fukushima, 96301, Japan
Fukuyama Hiroshima, 72109, Japan
Hiroshima-Shi Hiroshima, 73485, Japan
Sapporo Hokkaido, 003-0, Japan
Himeji-shi Hyogo, 67085, Japan
Itami Hyogo, 66485, Japan
Kobe City Hyogo, 65000, Japan
Kobe Hyogo, 65000, Japan
Bunkyo-ku Kanagawa, 11386, Japan
Yokohama-shi Kanagawa, 22108, Japan
Yokohama Kanagawa, 236-0, Japan
Yokohama Kanagawa, 241-8, Japan
Kumamoto-shi Kumamoto, 861-4, Japan
Natori-shi Miyagi, 981-1, Japan
Sendai-shi Miyagi, 98008, Japan
Hirakata-shi Osaka, 573-1, Japan
Kishiwada shi Osaka, 59685, Japan
Osaka-Sayama Osaka, 589-8, Japan
Sakai Osaka, 591-8, Japan
Hidaka Saitama, 350-1, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Chuo Tokyo, 104-0, Japan
Koto Tokyo, 135-8, Japan
Ube Shi Yamaguchi, 75502, Japan
Chiba , 26086, Japan
Fukuoka , 810-0, Japan
Fukuoka , 812-8, Japan
Niigata , 990-9, Japan
Tokyo , 16000, Japan
Toyama , 930-8, Japan
Wakayama , 64185, Japan
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Cheogju-si , 361-7, Korea, Republic of
Gyeonggi-do, , 10408, Korea, Republic of
Gyeonggi-do , 463-7, Korea, Republic of
Inchoen , 405-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06591, Korea, Republic of
Singapore , 11907, Singapore
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Hospitalet de Llobregat , 08907, Spain
Madrid , 28041, Spain
Majadahonda , 28222, Spain
Malaga , 29010, Spain
Zaragoza , 50009, Spain
Chiayi , 62247, Taiwan
Kaohsiung City , 807, Taiwan
Kaohsiung city , 82445, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Tainan , 736, Taiwan
Taipei City , 114, Taiwan
Taipei , 10002, Taiwan
Taipei , 10449, Taiwan
Taipei , 11031, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
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