Lung Cancer Clinical Trial
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
At least 1 measurable lesion as defined per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
Has mixed small cell lung cancer.
Participants with known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per local standard of care.
Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
NOTE: Other protocol and sub-study protocol defined criteria may apply
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There are 63 Locations for this study
Encinitas California, 92024, United States
Los Angeles California, 90067, United States
San Marcos California, 92069, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
New York New York, 10065, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Houston Texas, 77030, United States
Blacktown New South Wales, 2148, Australia
Camperdown New South Wales, 2050, Australia
Frenchs Forest New South Wales, 2086, Australia
Port Macquarie New South Wales, 2444, Australia
Nedlands Western Australia, 6009, Australia
Subiaco Western Australia, 6008, Australia
Barretos , 14784, Brazil
Londrina , 86015, Brazil
Porto Alegre , 90850, Brazil
Sao Jose do Rio Preto , 15090, Brazil
Sao Paulo , 01246, Brazil
Edmonton Alberta, T6G1Z, Canada
Hefei Anhui, 23060, China
Beijing Beijing, 10085, China
Fuzhou Fujian, 35001, China
Baoding Hebei, 07100, China
Harbin Heilongjiang, 15000, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43007, China
Nantong Jiangsu, 22600, China
Suzhou Jiangsu, 21500, China
Nanchang Jiangxi, 33200, China
Jining Shandong, 27200, China
Linyi Shandong, 27600, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20043, China
Taiyuan Shanxi, 03001, China
Tianjin Tianjin, 30006, China
Taizhou Zhejiang, 31700, China
Tbilisi , 0112, Georgia
Roma , 00144, Italy
Verona , 37134, Italy
Cheongjusi Chungcheongbukdo, 28644, Korea, Republic of
Goyangsi Gyeonggido, 10408, Korea, Republic of
Seongnamsi Gyeonggido, 13620, Korea, Republic of
Suwonsi Gyeonggido, 16247, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Georgetown , 10450, Malaysia
Johor Bahru , 81100, Malaysia
Kuantan , 25100, Malaysia
Kuching , 93586, Malaysia
Petaling Jaya , 46050, Malaysia
Chisinau , 2025, Moldova, Republic of
ClujNapoca , 40001, Romania
Singapore , 16858, Singapore
Barcelona , 08035, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Hat Yai , 90110, Thailand
Muang , 40002, Thailand
Muang , 50200, Thailand
Ongkharak , 26120, Thailand
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