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Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Sponsor: CatalYm GmbH
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
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)
Visugromab 6mg/kg
Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Nivolumab
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Placebo Saline Infusion
Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
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