Visugromab plus nivolumab, with or without docetaxel, for second-line treatment of metastatic non-squamous non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, blinded, placebo-controlled phase 2b trial conducted at multiple U.S. cancer centers that explores visugromab (an anti‑GDF‑15 antibody) given at two dose levels alongside nivolumab, with or without docetaxel, versus control regimens. The design includes an open-label safety run-in (Part A) followed by a randomized phase with four arms and an interim safety and preliminary efficacy analysis after 15 participants receive the expansion dose (Part B) before continuing to full enrollment (Part C). Eligible participants have stage IV non-squamous NSCLC without actionable driver mutations and must have progressed on prior first-line therapy that included a PD-(L)1 inhibitor. The trial will use standard radiologic RECIST v1.1 assessments and compare safety and early signals of clinical activity across arms.

Why it matters

Who can join: the full rules

Main Inclusion 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 targeted agent.
* Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.
* Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
* Participants must have life expectancy of at least 3 months as assessed by the Investigator.
* Participants must have ECOG performance status ≤1.

Main Exclusion Criteria:

* Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
* Participants must not have a prior malignancy requiring treatment.
* Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis
* Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

Where it's running

• University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
  Birmingham, Alabama, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• NYU Langone Hospital - Long Island
  Mineola, New York, United States Recruiting
• NYU Longone Health
  New York, New York, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting
• Hospital Esslingen GmbH
  Esslingen am Neckar, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Lena Lemke, MD
• Email: regulatory-004@catalym.com
• Phone: +49 89 200066440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.