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%).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT05635708

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 63 Locations for this study

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California Cancer Associates For Research and Excellence, Ccare Encinitas
Encinitas California, 92024, United States
Valkyrie Clinical Trials
Los Angeles California, 90067, United States
California Cancer Associates For Research and Excellence, Inc
San Marcos California, 92069, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York New York, 10065, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Oncology and Hematology Care Clinic Westside
Portland Oregon, 97225, United States
The University of Texas Md Anderson Cancer Center
Houston Texas, 77030, United States
Blacktown Cancer and Haematology Centre
Blacktown New South Wales, 2148, Australia
Chris Obrien Lifehouse
Camperdown New South Wales, 2050, Australia
Northern Beaches Hospital
Frenchs Forest New South Wales, 2086, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
One Clinical Research
Nedlands Western Australia, 6009, Australia
St John of God Health Care
Subiaco Western Australia, 6008, Australia
Hospital de Amor Barretos
Barretos , 14784, Brazil
Hospital Do Cancer de Londrina
Londrina , 86015, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre , 90850, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose do Rio Preto , 15090, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Sao Paulo , 01246, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G1Z, Canada
The Second Hospital of Anhui Medical University
Hefei Anhui, 23060, China
Chinese Pla General Hospital
Beijing Beijing, 10085, China
Fujian Cancer Hospital
Fuzhou Fujian, 35001, China
Affiliated Hospital of Hebei University
Baoding Hebei, 07100, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15000, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Nantong Tumor Hospital Branch North
Nantong Jiangsu, 22600, China
The First Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang Jiangxi, 33200, China
Jining No Peoples Hospital
Jining Shandong, 27200, China
Linyi Peoples Hospital
Linyi Shandong, 27600, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai Shanghai, 20003, China
Shanghai Pulmonary Hospital
Shanghai Shanghai, 20043, China
Shanxi Provincial Cancer Hospital
Taiyuan Shanxi, 03001, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China
Taizhou Hospital of Zhejiang
Taizhou Zhejiang, 31700, China
Arensia Exploratory Medicine Llc
Tbilisi , 0112, Georgia
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Roma , 00144, Italy
Centro Ricerche Cliniche Di Verona
Verona , 37134, Italy
Chungbuk National University Hospital
Cheongjusi Chungcheongbukdo, 28644, Korea, Republic of
National Cancer Center
Goyangsi Gyeonggido, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnamsi Gyeonggido, 13620, Korea, Republic of
The Catholic University of Korea, St Vincents Hospital
Suwonsi Gyeonggido, 16247, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Asan Medical Center
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Pulau Pinang Hospital
Georgetown , 10450, Malaysia
Sultan Ismail Hospital
Johor Bahru , 81100, Malaysia
Tengku Ampuan Afzan Hospital
Kuantan , 25100, Malaysia
Sarawak General Hospital
Kuching , 93586, Malaysia
Beacon Hospital
Petaling Jaya , 46050, Malaysia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau , 2025, Moldova, Republic of
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
ClujNapoca , 40001, Romania
National Cancer Centre Singapore
Singapore , 16858, Singapore
Hospital Universitario Vall Dhebron
Barcelona , 08035, Spain
Hospital Universitario de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai , 90110, Thailand
Srinagarind Hospital (Khon Kaen University)
Muang , 40002, Thailand
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang , 50200, Thailand
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak , 26120, Thailand

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT05635708

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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