Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer · Adult Solid Tumor · Sponsor: CatalYm GmbH
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).
This description comes directly from the study's public registry record.
Felix Lichtenegger, MD · +49 89 200066440 · regulatory-003@catalym.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| Yale Cancer Center | New Haven, Connecticut, United States | Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| NYU Longone Health | New York, New York, United States | Recruiting |
| Duke University Medical Center | Durham, North Carolina, United States | Recruiting |
| Medical University of South Carolina | Charleston, South Carolina, United States | Recruiting |
| Thorax Clinic Heidelberg | Heidelberg, Baden-Wurttemberg, Germany | Recruiting |
| University Hospital Würzburg | Würzburg, Bavaria, Germany | Recruiting |
| Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift | Bielefeld, North Rhine-Westphalia, Germany | Recruiting |
| Clinics Essen-Mitte | Essen, North Rhine-Westphalia, Germany | Recruiting |
| Foundation Bethanien Moers | Moers, North Rhine-Westphalia, Germany | Recruiting |
+ 28 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07098988