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Visugromab added to first-line immunochemotherapy for metastatic non-squamous NSCLC

A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)

Phase 2 Interventional CatalYm GmbH · NCT07098988

This trial tests whether adding visugromab to standard immunochemotherapy (pembrolizumab, pemetrexed, carboplatin) helps people with newly diagnosed metastatic non-squamous NSCLC who do not have targetable mutations.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment107 (estimated)
Ages18 Years and up
SexAll
SponsorCatalYm GmbH Industry-sponsored
Drugs / interventionsradiation, Visugromab, Pembrolizumab
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT07098988 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2b trial of the anti–GDF-15 antibody visugromab given with first-line immunochemotherapy (pembrolizumab, pemetrexed, carboplatin) in newly diagnosed metastatic non-squamous NSCLC. The study begins with a non-randomized safety run-in (Part A), includes an interim safety and preliminary efficacy analysis after 15 participants at the expansion dose (Part B), and then proceeds to a randomized expansion phase (Part C). Key entry requirements include no actionable driver mutations, measurable disease by RECIST v1.1, and available local PD-L1 TPS; prior adjuvant/neoadjuvant therapy is allowed if completed >12 months before metastasis. Participants are randomized to receive visugromab or matching placebo alongside standard immunochemotherapy with blinded assessment of safety and early efficacy signals.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed stage IV non-squamous NSCLC without actionable mutations, measurable disease, no prior systemic therapy for metastatic disease (prior adjuvant allowed if >12 months), and an available PD-L1 TPS result.

Not a fit: Patients with tumors that have actionable mutations requiring targeted therapy, those with squamous histology, or those who already received systemic treatment for metastatic disease are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, adding visugromab could increase tumor responses and delay disease progression when combined with standard immunochemotherapy, improving outcomes in first-line metastatic non-squamous NSCLC.

How similar studies have performed: While combining chemotherapy with immune checkpoint inhibitors is an established effective approach, targeting GDF-15 with visugromab is a relatively novel strategy with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion 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 the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy.
* Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.
* Availability of a tissue/histological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted.
* Age ≥ 18 years on the day of signing the informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Adequate organ function (bone marrow, hepatic, renal function and coagulation).

Main Exclusion Criteria:

* Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).
* Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \< 3 months prior to planned treatment start).
* Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug.
* Received potentially curative radiation therapy to the lung that is \> 30 Gy within 6 months prior to the first dose of study drug.
* Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug.
* Expected to require any other form of antineoplastic therapy while on trial.
* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.
* Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* 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 with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions.
* Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri/myocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start.
* Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.
* Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.

Where this trial is running

Birmingham, Alabama and 36 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.