Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

NCT Number	NCT07098988
Lead Sponsor	CatalYm GmbH
Conditions	Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Enrollment	107 participants
Start Date	2025-08-01
Primary Completion	2029-03-31 (estimated)
Study Completion	2031-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-10