A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Part of paid clinical trials in Ocala, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT06472076
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

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

Interventions

  • Dostarlimab — BIOLOGICAL
    Dostarlimab will be administered.
  • Belrestotug — BIOLOGICAL
    Belrestotug will be administered.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Key Dates

Start date
Jun 10, 2024
Status verified
Sep 2025
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

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

Arms

  • Experimental: Dostarlimab plus belrestotug
  • Active Comparator: Pembrolizumab plus placebo

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 138 weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteOcalaFlorida34474-
GSK Investigational SiteHonoluluHawaii96819-
GSK Investigational SiteLexingtonKentucky40503-
GSK Investigational SiteLexingtonKentucky40509-
GSK Investigational SiteAnn ArborMichigan48106-
GSK Investigational SiteOmahaNebraska68114-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteOlympiaWashington98506-

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