RecruitingPhase 2NCT07246863

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

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)

Sponsor

CatalYm GmbH

Enrollment

131 participants

Start Date

Oct 7, 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) 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 part with 4 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 tests adding visugromab (a drug that blocks a protein called CCL2 which helps tumors evade the immune system) to nivolumab (immunotherapy) with or without docetaxel (chemotherapy) as a second-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC) — lung cancer that has spread and did not respond to first-line treatment. **You may be eligible if...** - You have stage IV non-squamous NSCLC confirmed by biopsy - Your cancer does not have actionable mutations (like EGFR or ALK) that can be targeted with other drugs - You have already tried one line of systemic treatment for metastatic NSCLC which included immunotherapy - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have actionable mutations (EGFR, ALK, etc.) that have approved targeted therapies - You have had more than one prior line of treatment for metastatic disease - You have active autoimmune disease or are on immune-suppressing drugs - You have brain metastases that are untreated or unstable 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 RDE (recommended dose for expansion)

Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

BIOLOGICALVisugromab 6mg/kg

Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

BIOLOGICALNivolumab

Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

OTHERPlacebo Saline Infusion

Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

DRUGDocetaxel

Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Locations(15)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Birmingham, Alabama, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Duke University Medical Center

Durham, North Carolina, United States

Hospital Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany

University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology

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

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

Forlì, Emilia-Romagna, Italy

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

Ravenna, Italy

University Hospital of Jaen

Jaén, Andalusia, Spain

Regional University Hospital of Malaga

Málaga, Andalusia, Spain

University Hospital 12 de Octubre

Madrid, Madrid, Spain

University Hospital Lucus Augusti (HULA)

Lugo, Spain

University Hospital Basel

Basel, Switzerland

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07246863

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