OncRef

Clinical Trial: NCT03739710

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:GlaxoSmithKline
Information Provided By:GlaxoSmithKline
Last Update Posted:2025-06-15

Study Overview

Brief Summary

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.

Official Title

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

Conditions

Neoplasms

Intervention / Treatment

  • Drug: Docetaxel
  • Drug: Feladilimab
  • Drug: Ipilimumab
  • Drug: GSK4428859A
  • Drug: Dostarlimab
  • Drug: GSK6097608

Other Study ID Numbers

  • 205801
  • 2018-001316-29
  • 2018

Start Date (Actual)

2019-01-24

Primary Completion Date (Actual)

2024-05-02

Study Completion Date (Actual)

2024-05-02

Enrollment (Actual)

175

Study Type

Interventional

Phase

Phase 2