Active Not RecruitingPhase 2NCT05635708

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

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%).

Checked against the public recordLast updated Apr 15, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 2
U.S. locations61
SponsorBeiGene
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
BeiGene
Interventions being studied
Drug: Tislelizumab; Drug: BGB-A445; Drug: LBL-007; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: BGB-15025
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

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Public criteria

Who may be able to participate

Key Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. 2. No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment. 3. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible. 4. At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Key Exclusion Criteria: 1. Diagnosis of mixed small cell lung cancer. 2. Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to: * Epidermal growth factor receptor (EGFR) mutations * Anaplastic lymphoma kinase (ALK) rearrangements * B-Raf proto-oncogene (BRAF) mutations * Rearranged during transfection (RET) fusions * c-ros oncogene 1 (ROS1) rearrangements 3. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded. 4. Prior treatment with immune-based therapies that target immune checkpoint pathways, including: * PD-1 (programmed cell death protein 1) inhibitors * PD-L1 (programmed death-ligand 1) inhibitors * PD-L2 (programmed death-ligand 2) inhibitors * TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors * LAG-3 (lymphocyte activation gene 3) inhibitors 5. Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present. 6. Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment. 7. Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease. Note: Additional protocol-defined and sub-study-specific criteria may apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Valkyrie Clinical TrialsLos Angeles, California
  • Massachusetts General HospitalBoston, Massachusetts
  • Memorial Sloan Kettering Cancer Center MskccNew York, New York
  • Providence Portland Medical CenterPortland, Oregon
  • The University of Texas Md Anderson Cancer CenterHouston, Texas
  • Blacktown Cancer and Haematology CentreBlacktown, New South Wales
  • Chris Obrien LifehouseCamperdown, New South Wales
  • Northern Beaches HospitalFrenchs Forest, New South Wales
  • Port Macquarie Base HospitalPort Macquarie, New South Wales
  • One Clinical ResearchNedlands, Western Australia
  • St John of God Health CareSubiaco, Western Australia
  • Hospital de Amor BarretosBarretos

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 15, 2026. Always confirm current availability with the study team.

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