A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer.

Phase 1

Recruiting

• Conditions: Metastatic Non-small Cell Lung Cancer, Non-small Cell Lung Cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502738-18-00
• Lead Sponsor: Beigene Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 214

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, NOTE: Other protocol and sub-study protocol defined criteria may apply

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified