Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Start Date
8/1/2025
Completion Date
3/31/2031
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) 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 Criteria
Age Range: 18 years to No maximum
Interventions
Visugromab
Matching placebo for visugromab
Pembrolizumab 200 mg Q3W
Pemetrexed 500 mg/m^2
Carboplatin AUC 5
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294-2936
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Yale Cancer Center
New Haven, Connecticut 06519
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
NYU Longone Health
New York, New York 10016
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Thorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg 69126
Germany
University Hospital Würzburg
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
Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology
Großhansdorf, Schleswig-Holstein 22927
Germany
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Meldola, Forli 47014
Italy
Oncology Reference Center
Aviano, 33081
Italy
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, 48121
Italy
National Cancer Institute Regina Elena, IRCCS
Rome, 00144
Italy
MED-Polonia, Sp. z o.o. (LLC)
Poznan, 60-693
Poland
Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology
Prabuty, 82-550
Poland
"Sf. Nectarie" Oncology Center, Department of Medical Oncology
Craiova, Dolj 200542
Romania
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, 110283
Romania
Clinica Polisano S.R.L.
Sibiu, 550253
Romania
SC Oncomed SRL, Department of Medical Oncology
Timișoara, +40 () 727 774 974
Romania
University Hospital of Jaen
Jaén, Andalusia 23007
Spain
Regional University Hospital of Malaga
Málaga, Andalusia 29010
Spain
University Hospital Virgen Macarena
Seville, Andalusia 41009
Spain
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia 41013
Spain
University Hospital Marques de Valdecilla (HUMV)
Santander, Cantabria 39008
Spain
Hospital del Mar
Barcelona, Catalonia 08003
Spain
Hospital Quiron Dexeus Barcelona
Barcelona, Catalonia 08028
Spain
University Clinic of Navarra - Pamplona
Pamplona, Chartered Community of Navarre 31008
Spain
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Galicia 15706
Spain
START- Rioja
Rioja, La Rioja 26006
Spain
University Hospital 12 de Octubre
Madrid, Madrid 28041
Spain
University Hospital HM Sanchinarro
Madrid, Madrid 28050
Spain
University Hospital Lucus Augusti (HULA)
Lugo, 27003
Spain
MD Anderson International Cancer Center Spain
Madrid, 28033
Spain
University Hospital Basel
Basel, Basel 4031
Switzerland
Fribourg Cantonal Hospital
Fribourg, Canton of Fribourg 1708
Switzerland
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, Canton of St. Gallen 9007
Switzerland