A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with high levels of programmed cell death ligand-1 (PD-L1), locally advanced/recurrent or untreated metastatic non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated May 12, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- BeiGene
- Interventions being studied
- Drug: Tislelizumab; Drug: Ociperlimab; Drug: Pembrolizumab; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Providence Medical Foundation St Jude Heritage HealthcareFullerton, California
- Valkyrie Clinical TrialsLos Angeles, California
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates OcalaOcala, Florida
- Advent Health Cancer InstituteOrlando, Florida
- Goshen Center For Cancer CareGoshen, Indiana
- Baptist Health LexingtonLexington, Kentucky
- University Medical Center New Orleans West Jefferson Medical CenterNew Orleans, Louisiana
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)Saint Paul, Minnesota
- West Penn HospitalPittsburgh, Pennsylvania
- Centro Medical AustralBuenos Aires
- Centro Para La Atencion Del Paciente Oncologico (Caipo)San Miguel de Tucumán
- Concord Repatriation General HospitalConcord, New South Wales
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 12, 2026. Always confirm current availability with the study team.