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

Trial Details

NCT ID
NCT07098988
Phase
PHASE2
Sponsor
CatalYm GmbH
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Visugromab
  • Matching placebo for visugromab
  • Pembrolizumab 200 mg Q3W
  • Pemetrexed 500 mg/m^2
  • Carboplatin AUC 5
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • New York, New York, United States|40.71427,-74.00597
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
  • Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
  • Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1.
  • Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if…

For full eligibility, visit ClinicalTrials.gov.

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