Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rak płuca niedrobnokomórkowy w stadium IV, który nie jest typu płaskonabłonkowego.
- •Brak mutacji genetycznych, które można leczyć innymi dostępnymi lekami.
- •Potwierdzone przez lekarza zmiany widoczne w badaniach obrazowych.
- •Nie były leczone wcześniej na zaawansowanego raka płuca.
- •Badanie poziomu PD-L1 we krwi lub tkance nowotworowej (szczegóły u lekarza).
- •Dostępna próbka tkanki nowotworowej do dalszych badań i zgoda na jej wykorzystanie.
- •Wiek co najmniej 18 lat.
- •Ogólny stan zdrowia pozwalający na aktywność (skala ECOG 0-1).
✗ Disqualifies
- •Rak płuca typu płaskonabłonkowego lub drobnokomórkowego.
- •Aktywne lub niedawne poważne problemy z sercem lub innymi narządami.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (40)
University of Alabama at Birmingham
Birmingham, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Yale Cancer Center
New Haven, United States
Moffitt Cancer Center
Tampa, United States
NYU Longone Health
New York, United States
Duke University Medical Center
Durham, United States
Medical University of South Carolina
Charleston, United States
Thorax Clinic Heidelberg
Heidelberg, Germany
University Hospital Würzburg
Würzburg, Germany
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Bielefeld, Germany
Clinics Essen-Mitte
Essen, Germany
Foundation Bethanien Moers
Moers, Germany
Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology
Großhansdorf, Germany
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Meldola, Italy
Oncology Reference Center
Aviano, Italy
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, Italy
National Cancer Institute Regina Elena, IRCCS
Rome, Italy
MED-Polonia, Sp. z o.o. (LLC)
Poznan, Poland
Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology
Prabuty, Poland
"Sf. Nectarie" Oncology Center, Department of Medical Oncology
Craiova, Romania
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, Romania
Clinica Polisano S.R.L.
Sibiu, Romania
SC Oncomed SRL, Department of Medical Oncology
Timișoara, Romania
University Hospital of Jaen
Jaén, Spain
Regional University Hospital of Malaga
Málaga, Spain
University Hospital Virgen Macarena
Seville, Spain
University Hospital Virgen del Rocio (HUVR)
Seville, Spain
University Hospital Marques de Valdecilla (HUMV)
Santander, Spain
Hospital del Mar
Barcelona, Spain
Hospital Quiron Dexeus Barcelona
Barcelona, Spain
University Clinic of Navarra - Pamplona
Pamplona, Spain
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Spain
START- Rioja
Rioja, Spain
University Hospital 12 de Octubre
Madrid, Spain
University Hospital HM Sanchinarro
Madrid, Spain
University Hospital Lucus Augusti (HULA)
Lugo, Spain
MD Anderson International Cancer Center Spain
Madrid, Spain
University Hospital Basel
Basel, Switzerland
Fribourg Cantonal Hospital
Fribourg, Switzerland
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, Switzerland
Trial contact
Felix Lichtenegger, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
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