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

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 42 → 51 locations
    • Interventions: Carboplatin AUC 5 (Drug), Matching placebo for visugromab (Drug), Pembrolizumab 200 mg Q3W (Biological), Pemetrexed 500 mg/m^2 (Drug)… to Carboplatin AUC 5 (Drug), Matching placebo for visugromab (Drug), Pembrolizumab 200 mg Q3W (Biological), Pemetrexed 500 mg/m^2 (Drug)…
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 13 entries
  2. Study sites: 40 to 42v6
  3. Trial sites expanded: 37 → 40 locationsv5
  4. Trial sites expanded: 25 → 37 locationsv4
  5. Study sites: 13 to 25
    • Eligibility criteria expanded, about 5 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 13
    • Start date changed from estimate of Jul 30, 2025 to Aug 1, 2025
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07098988
Lead Sponsor CatalYm GmbH
Conditions
(from sponsor)		 Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov