Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Start Date
10/7/2025
Completion Date
10/1/2031
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 Criteria
Age Range: 18 years to No maximum
Interventions
Visugromab RDE (recommended dose for expansion)
Visugromab 6mg/kg
Nivolumab
Placebo Saline Infusion
Docetaxel
Conditions
Locations
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama 35294-3300
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
NYU Longone Health
New York, New York 10016
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Hospital Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg 73730
Germany
Thorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg 69126
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 97080
Germany
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Bielefeld, North Rhine-Westphalia 33611
Germany
Clinics Essen-Mitte
Essen, North Rhine-Westphalia 45136
Germany
Foundation Bethanien Moers
Moers, North Rhine-Westphalia 47441
Germany
Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST
Forlì, Emilia-Romagna 47014
Italy
Oncology Reference Center
Aviano, Friuli Venezia Giulia 33081
Italy
National Cancer Institute Regina Elena, IRCCS
Rome, Lazio 00144
Italy
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, 48121
Italy
MED-Polonia, Sp. z o.o. (LLC)
Poznan, Greater Poland Voivodeship 60693
Poland
Sf. Nectarie Oncology Center
Craiova, Dolj 200542
Romania
Clinica Polisano S.R.L
Sibiu, Sibiu County 55023
Romania
SC Oncomed SRL
Timișoara, Timiș County 300239
Romania
University Hospital of Jaen
Jaén, Andalusia 23007
Spain
Regional University Hospital of Malaga
Málaga, Andalusia 29010
Spain
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia 41013
Spain
Hospital Clinic of Barcelona
Barcelona, Catalonia 08036
Spain
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Galicia 15706
Spain
University Hospital of Girona Dr. Josep Trueta
Girona, Girona 17007
Spain
START- Rioja
Logroño, La Rioja 26006
Spain
Clínica Universidad de Navarra
Madrid, Madrid 28027
Spain
University Hospital 12 de Octubre
Madrid, Madrid 28041
Spain
University Hospital HM Sanchinarro
Madrid, Madrid 28050
Spain
University Clinic of Navarra - Pamplona
Pamplona, Navarre 31008
Spain
University Hospital Lucus Augusti (HULA)
Lugo, 27003
Spain
University Hospital Basel
Basel, 4031
Switzerland
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, CH-9007
Switzerland