drugset / Trial / NCT03739710

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

NCT03739710

Phase 2 Completed 175 enrolled GlaxoSmithKline iTeos Belgium SA · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-01-24
Primary completion
2024-05-02
Completion
2024-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Belrestotug Monoclonal antibody
Subject Docetaxel Small molecule
Subject Dostarlimab Monoclonal antibody
Subject Feladilimab Monoclonal antibody
Subject Ipilimumab Monoclonal antibody
Subject Nelistotug Monoclonal antibody

Indications