A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Part of paid clinical trials in Plantation, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT05565378
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered.
  • Dostarlimab — DRUG
    Dostarlimab will be administered
  • Belrestotug — DRUG
    Belrestotug will be administered.
  • Nelistotug — DRUG
    Nelistotug will be administered.

Study Details

This study will monitor the safety of novel immunotherapy combinations in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells \[TC\]/ Tumor proportion score \[TPS\] \>= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

Key Dates

Start date
Oct 14, 2022
Status verified
Jan 2026
Primary completion
Feb 26, 2027
Completion
Feb 26, 2027

Study Design

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

Arms

  • Active Comparator: Pembrolizumab Monotherapy
    Participants will be administered with pembrolizumab as monotherapy in a fixed dose.
  • Experimental: Dostarlimab Monotherapy
    Participants will be administered with dostarlimab as monotherapy in a fixed dose.
  • Experimental: Substudy 1A
    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).
  • Experimental: Substudy 1B
    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).
  • Experimental: Substudy 1C
    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).
  • Experimental: Substudy 2A
    Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 228 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePlantationFlorida33322-
GSK Investigational SiteAlbuquerqueNew Mexico87131-
GSK Investigational SiteChattanoogaTennessee37404-
GSK Investigational SiteMorgantownWest Virginia26506-

Find similar trials in Plantation, FL

By research site
GSK Investigational Site· Plantation, FLGSK Investigational Site· Albuquerque, NMGSK Investigational Site· Chattanooga, TNGSK Investigational Site· Morgantown, WV

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