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 par

Trial Details

NCT ID
NCT07246863
Phase
PHASE2
Sponsor
CatalYm GmbH
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Visugromab RDE (recommended dose for expansion)
  • Visugromab 6mg/kg
  • Nivolumab
  • Placebo Saline Infusion
  • Docetaxel
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • New York, New York, United States|40.71427,-74.00597
  • Durham, North Carolina, United States|35.99403,-78.89862
  • Esslingen am Neckar, Baden-Wurttemberg, Germany|48.73961,9.30473

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
  • Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available ta…
  • Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (C…
  • Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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