Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L 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) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 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	NCT07246863
Lead Sponsor	CatalYm GmbH
Conditions	Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Enrollment	131 participants
Start Date	2025-10-07
Primary Completion	2029-10-01 (estimated)
Study Completion	2031-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-29