NCT03739710

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel will be administered.
DRUG	Feladilimab	Feladilimab will be administered.
DRUG	Ipilimumab	Ipilimumab will be administered.
DRUG	GSK4428859A	GSK4428859A/EOS884448 will be administered.
DRUG	Dostarlimab	Dostarlimab will be administered.
DRUG	GSK6097608	GSK6097608 will be administered.

Timeline

• Start date: 2019-01-24
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2018-11-14
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

57 sites across 12 countries: United States, Canada, France, Germany, Italy, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study