Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT03739710
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    Docetaxel will be administered.
  • Feladilimab — DRUG
    Feladilimab will be administered.
  • Ipilimumab — DRUG
    Ipilimumab will be administered.
  • GSK4428859A — DRUG
    GSK4428859A/EOS884448 will be administered.
  • Dostarlimab — DRUG
    Dostarlimab will be administered.
  • GSK6097608 — DRUG
    GSK6097608 will be administered.

Study Details

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

Key Dates

Start date
Jan 24, 2019
Status verified
Jun 2025
Primary completion
May 2, 2024
Completion
May 2, 2024

Study Design

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

Arms

  • Experimental: Part 1: Participants receiving feladilimab and ipilimumab
  • Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug
  • Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608
  • Active Comparator: Part 2: Participants receiving SoC: docetaxel
  • Experimental: Part 2: Participants receiving feladilimab and docetaxel

Primary Outcome Measure

Number of Participants Randomized Across Sub-studies [ Time Frame: Day 1 ]

Locations (7)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90025-
GSK Investigational SiteSt LouisMissouri63110-1093-
GSK Investigational SiteThe BronxNew York10461-2375-
GSK Investigational SitePinehurstNorth Carolina28374-
GSK Investigational SiteChattanoogaTennessee37404-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteDallasTexas75230-

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