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 for which a targeted therapy has been approved by the local health authority will be excluded.
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:

200

Study ID:

NCT05635708

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 15 Locations for this study

See Locations Near You

Valkyrie Clinical Trials
Los Angeles California, 90067, United States
Blacktown Cancer and Haematology Centre
Blacktown New South Wales, 2148, 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
The Second Hospital of Anhui Medical University
Hefei Anhui, 23060, China
Fujian Cancer Hospital
Fuzhou Fujian, 35001, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Hubei Cancer Hospital
Wuhan Hubei, 40003, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang Jiangxi, 33200, China
Jining No Peoples Hospital
Jining Shandong, 27200, China
Shanghai Pulmonary Hospital
Shanghai Shanghai, 20043, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China
Taizhou Hospital of Zhejiang
Taizhou Zhejiang, 31700, China
National Cancer Centre Singapore
Singapore , 16858, Singapore

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT05635708

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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