Status:
ACTIVE_NOT_RECRUITING
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
Lead Sponsor:
BeiGene
Conditions:
Non-small Cell Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated me...
Eligibility Criteria
Inclusion
- Key
- 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.
- No prior systemic treatment for metastatic NSCLC.
- Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
- Tumors with PD-L1 expressed in ≥ 50% tumor cells.
- At least 1 measurable lesion as defined per RECIST v1.1.
- ECOG Performance Status ≤ 1.
- Key
Exclusion
- Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
- 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.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT04746924
Start Date
June 8 2021
End Date
March 31 2026
Last Update
June 24 2025
Active Locations (218)
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1
Providence Medical Foundation St Jude Heritage Healthcare
Fullerton, California, United States, 92835
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
3
Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
Ocala, Florida, United States, 34474
4
Advent Health Cancer Institute
Orlando, Florida, United States, 32804