RecruitingPhase 2NCT07098988

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic 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)

Sponsor

CatalYm GmbH

Enrollment

107 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor

Summary

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 efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called visugromab combined with immunotherapy and chemotherapy as a first treatment for people with newly diagnosed stage IV non-squamous lung cancer (NSCLC) that does not have targetable gene mutations. Visugromab works by blocking a protein that may help cancer cells survive. **You may be eligible if...** - You are 18 or older - You have newly diagnosed advanced non-squamous NSCLC without mutations like EGFR or ALK - You have not had prior treatment for advanced or metastatic lung cancer - You have measurable tumor on scans - Your general health is good (ECOG 0–1) - Tissue biopsy from your tumor is available for research **You may NOT be eligible if...** - You have squamous cell or small cell lung cancer - You have had a major organ failure (heart, liver, kidney) in the past 3 months - You have uncontrolled heart disease, including recent heart attack or stroke - You have active autoimmune disease requiring systemic treatment - You are pregnant or planning to become pregnant - You take metformin for diabetes - You have active interstitial lung disease or pneumonitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVisugromab

Participants receive Visugromab (recommended dose) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

DRUGMatching placebo for visugromab

Participants receive Matching Placebo intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

BIOLOGICALPembrolizumab 200 mg Q3W

Participants receive Pembrolizumab 200 mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion.

DRUGPemetrexed 500 mg/m^2

Participants receive Pemetrexed 500 mg/m\^2 IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

DRUGCarboplatin AUC 5

Participants receive Carboplatin target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) on Day 1 of each 21-day cycle for four cycles.

Locations(25)

University of Alabama at Birmingham

Birmingham, Alabama, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Duke University Medical Center

Durham, North Carolina, United States

Thorax Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

University Hospital Würzburg

Würzburg, Bavaria, Germany

Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift

Bielefeld, North Rhine-Westphalia, Germany

Clinics Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology

Großhansdorf, Schleswig-Holstein, Germany

Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST

Meldola, Forli, Italy

Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department

Ravenna, Italy

National Cancer Institute Regina Elena, IRCCS

Rome, Italy

"Sf. Nectarie" Oncology Center, Department of Medical Oncology

Craiova, Dolj, Romania

Gral Medical S.R.L. - Oncofort Hospital

Piteşti, Romania

Clinica Polisano S.R.L.

Sibiu, Romania

SC Oncomed SRL, Department of Medical Oncology

Timișoara, Romania

University Hospital of Jaen

Jaén, Andalusia, Spain

Regional University Hospital of Malaga

Málaga, Andalusia, Spain

University Hospital Virgen Macarena

Seville, Andalusia, Spain

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, Galicia, Spain

University Hospital 12 de Octubre

Madrid, Madrid, Spain

University Hospital Lucus Augusti (HULA)

Lugo, Spain

University Hospital Basel

Basel, Basel, Switzerland

Fribourg Cantonal Hospital

Fribourg, Canton of Fribourg, Switzerland

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, Canton of St. Gallen, Switzerland

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NCT07098988

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