Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of ociperlimab with tislelizumab and chemotherapy compared with treatment with tislelizumab and chemotherapy in participants with metastatic non-small cell lung cancer (NSCLC)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria:

1. Histologically confirmed metastatic (Stage IV) squamous or non-squamous NSCLC.

2. Treatment-naive for metastatic squamous or non-squamous NSCLC.

3. Agreement to provide archival tissue or fresh biopsy for the prospectively determination of PD-L1 levels and retrospective analysis of other biomarkers.

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

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5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

1. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.

2. Prior therapy with an anti-programmed cell death protein (PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

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

4. 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.