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NCT07098988

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

Recruiting now Phase 2 Last updated 27 February 2026
What this trial tests

Phase 2 trial testing Visugromab in Metastatic Non-Squamous Non-Small Cell Lung Cancer in 107 participants. Currently enrolling.

Timeline
1 August 2025
Primary endpoint
31 March 2029
31 March 2031

Quick facts

Lead sponsorCatalYm GmbH
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment107
Start date1 August 2025
Primary completion31 March 2029
Estimated completion31 March 2031
Sites25 locations across Italy, Germany, Romania, Switzerland, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

CatalYm GmbH — full company profile →

Who can join

18 and older, any sex, with Metastatic Non-Squamous Non-Small Cell Lung Cancer or Adult Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Metastatic Non-Squamous Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other CatalYm GmbH trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07098988.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing