Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
In brief
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).
Key facts
- Study ID
- NCT07098988
- Run by
- CatalYm GmbH
- People needed
- 107
- Starts
- 2025-08-01
- Expected to finish
- 2031-03-31
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- NYU Longone Health — New York, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Thorax Clinic Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
- University Hospital Würzburg — Würzburg, Bavaria, Germany (enrolling)
- Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift — Bielefeld, North Rhine-Westphalia, Germany (enrolling)
- Clinics Essen-Mitte — Essen, North Rhine-Westphalia, Germany (enrolling)
- Foundation Bethanien Moers — Moers, North Rhine-Westphalia, Germany (enrolling)
- Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology — Großhansdorf, Schleswig-Holstein, Germany (enrolling)
- Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST — Meldola, Forli, Italy (enrolling)
- Oncology Reference Center — Aviano, Italy (enrolling)
- Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department — Ravenna, Italy (enrolling)
- National Cancer Institute Regina Elena, IRCCS — Rome, Italy (enrolling)
- MED-Polonia, Sp. z o.o. (LLC) — Poznan, Poland (enrolling)
- Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology — Prabuty, Poland (enrolling)
- "Sf. Nectarie" Oncology Center, Department of Medical Oncology — Craiova, Dolj, Romania (enrolling)
- Gral Medical S.R.L. - Oncofort Hospital — Piteşti, Romania (enrolling)
- Clinica Polisano S.R.L. — Sibiu, Romania (enrolling)
- SC Oncomed SRL, Department of Medical Oncology — Timișoara, Romania (enrolling)
- University Hospital of Jaen — Jaén, Andalusia, Spain (enrolling)
- Regional University Hospital of Malaga — Málaga, Andalusia, Spain (enrolling)
Full record on ClinicalTrials.gov
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