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About
This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only participantswho have evaluable PD-L1 results are eligible.
At least one measurable lesion by the investigator per RECIST v1.1.
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Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Key Exclusion Criteria:
Known mutations in:
Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
272 participants in 2 patient groups, including a placebo group
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Central trial contact
BeiGene, USA, Inc
Data sourced from clinicaltrials.gov
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