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

  • STATUS
    Recruiting
  • End date
    Mar 20, 2025
  • participants needed
    605
  • sponsor
    BeiGene
Updated on 20 June 2021
measurable disease
chemoradiotherapy
pembrolizumab
recurrent non-small cell lung cancer
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Placebo, Pembrolizumab, tislelizumab, Ociperlimab
Clinical Study IdentifierNCT04746924
SponsorBeiGene
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 (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
Tumors with PD-L1 tumor cell 50% expression as centrally determined
At least 1 measurable lesion as defined per RECIST v1.1

Exclusion Criteria

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