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

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

Phase 2 Interventional CatalYm GmbH · NCT07246863

This trial tests whether adding the anti-GDF-15 antibody visugromab to nivolumab, with or without docetaxel, helps people with metastatic non-squamous NSCLC whose cancer progressed after first-line treatment that included a checkpoint inhibitor.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment131 (estimated)
Ages18 Years and up
SexAll
SponsorCatalYm GmbH Industry-sponsored
Drugs / interventionsVisugromab, Nivolumab
Locations15 sites (Birmingham, Alabama and 14 other locations)
Trial IDNCT07246863 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with stage IV non-squamous NSCLC without actionable mutations, measurable disease, and documented progression while receiving a prior regimen that included an approved PD-(L)1 checkpoint inhibitor after at least 12 weeks of exposure.

Not a fit: Patients with actionable driver mutations, those who stopped prior checkpoint inhibitors for reasons other than progression, patients with squamous histology, or those unable to receive study treatments are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could improve tumor control or prolong benefit for patients whose non-squamous NSCLC progressed after prior checkpoint inhibitor therapy.

How similar studies have performed: This approach is novel because anti‑GDF‑15 antibodies are early‑stage and have limited clinical data, although nivolumab and docetaxel as components have established activity in this setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Non-Squamous Non-Small Cell Lung CancerAdult Solid TumorCTL-002VisugromabGDF-15
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.