A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Pembrolizumab

Criteria

Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.

2. No prior systemic treatment for metastatic NSCLC.

3. Agreement to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or 6 to 15 freshly cut unstained slides) or fresh biopsy (if archival tissue is not available) for prospective central evaluation of programmed cell death ligand-1 (PD-L1) levels and retrospective analysis of other biomarkers.

4. Tumors with PD-L1 tumor cell ≥ 50% expression as centrally determined.

5. At least 1 measurable lesion as defined per RECIST v1.1.

Key Exclusion Criteria:

1. Known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase fusion oncogene.

2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

5. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (for example, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.