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

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05635708

Patient View

This study evaluates the antitumor activity, safety, and tolerability of tislelizumab with investigational agents, with or without chemotherapy, in NSCLC patients. Eligible participants have advanced or metastatic NSCLC, no prior systemic treatment, and measurable PD-L1 expression. Interventions include intravenous drugs like BGB-A445 and oral BGB-15025.

Patient Parameters

Program Overview

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

  1. 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.
  2. 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.
  3. 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.
  4. At least 1 measurable lesion as defined per RECIST v1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria

  1. Has mixed small cell lung cancer.
  2. 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.
  3. 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.
  4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
  5. 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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