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

Part of paid clinical trials in Fullerton, California.

Sponsor
BeiGene
Study ID
NCT04746924
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    Tislelizumab is a monoclonal antibody formulated for intravenous injection.
  • Ociperlimab — DRUG
    Ociperlimab is a monoclonal antibody formulated for intravenous injection.
  • Pembrolizumab — DRUG
    Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
  • Placebo — DRUG
    Placebo infusions will consist of a sterile, normal saline solution.

Study Details

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).

Key Dates

Start date
May 24, 2021
Status verified
Apr 2026
Primary completion
May 30, 2025
Completion
Mar 18, 2026

Study Design

Enrollment
669 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Ociperlimab plus Tislelizumab
    Participants received ociperlimab 900 mg and tislelizumab 200 mg intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
  • Active Comparator: Arm B: Pembrolizumab plus Placebo
    Participants received pembrolizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
  • Placebo Comparator: Arm C: Tislelizumab plus Placebo
    Participants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
  • Experimental: Safety Run-In Substudy
    Japanese participants received ociperlimab 900 mg and tislelizumab 200 mg every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.

Primary Outcome Measure

Overall Survival (OS) in Arms A and B [ Time Frame: From randomization until the end of the study. Maximum time on study was 45.0 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Providence Medical Foundation St Jude Heritage HealthcareFullertonCalifornia92835-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Ocala Oncology Center Pl Dba Florida Cancer Affiliates OcalaOcalaFlorida34474-
Advent Health Cancer InstituteOrlandoFlorida32804-
Goshen Center For Cancer CareGoshenIndiana46526-
Baptist Health LexingtonLexingtonKentucky40503-
University Medical Center New Orleans West Jefferson Medical CenterNew OrleansLouisiana70112-
Metro Minnesota Community Oncology Research Consortium (Mmcorc)Saint PaulMinnesota55101-
West Penn HospitalPittsburghPennsylvania15224-

Related coverage on Hipa.ai

Find similar trials in Fullerton, CA

By condition
Lung cancer
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OncologyLung oncologyLung disease
By research site
Providence Medical Foundation St Jude Heritage Healthcare· Fullerton, CAValkyrie Clinical Trials· Los Angeles, CAOcala Oncology Center Pl Dba Florida Cancer Affiliates Ocala· Ocala, FLAdvent Health Cancer Institute· Orlando, FLGoshen Center For Cancer Care· Goshen, INBaptist Health Lexington· Lexington, KY

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