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RECRUITING
NCT07246863
PHASE2

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

Sponsor: CatalYm GmbH

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

131

Start Date

2025-10-07

Completion Date

2031-10-01

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

Visugromab RDE (recommended dose for expansion)

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

BIOLOGICAL

Visugromab 6mg/kg

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

BIOLOGICAL

Nivolumab

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

OTHER

Placebo Saline Infusion

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

DRUG

Docetaxel

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

Locations (13)

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

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

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