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

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04746924

Patient View

This study assesses the efficacy and safety of ociperlimab + tislelizumab versus pembrolizumab in adults with PD-L1 high NSCLC. Eligible participants have untreated, advanced, or metastatic NSCLC, with PD-L1 expression ≥ 50%, and ECOG ≤ 1. Interventions include intravenous administration of tislelizumab, ociperlimab, pembrolizumab, or placebo.

Patient Parameters

Program Overview

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 metastatic NSCLC.

Eligibility Criteria

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 RECIST v1.1.
  6. 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

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