A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
About the study
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%).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- 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.
- 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.
- 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.
- At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Diagnosis of mixed small cell lung cancer.
- 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
- Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
- 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
- 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.
- Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment.
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non-small Cell Lung Cancer,Metastatic Non-small Cell Lung Cancer
Age (in years)
18+
Phase
PHASE2
Participants needed
400
Est. Completion Date
Oct 31, 2025
Treatment type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT05635708
Study number
BGB-LC-201
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