Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L 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) 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).
Key facts
- Study ID
- NCT07246863
- Run by
- CatalYm GmbH
- People needed
- 131
- Starts
- 2025-10-07
- Expected to finish
- 2031-10-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) — Birmingham, Alabama, United States (enrolling)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- NYU Langone Hospital - Long Island — Mineola, New York, United States (enrolling)
- NYU Longone Health — New York, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Hospital Esslingen GmbH — Esslingen am Neckar, Baden-Wurttemberg, Germany (enrolling)
- Thorax Clinic Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
- University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology — 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)
- Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST — Forlì, Emilia-Romagna, Italy (enrolling)
- Oncology Reference Center — Aviano, Friuli Venezia Giulia, Italy (enrolling)
- National Cancer Institute Regina Elena, IRCCS — Rome, Lazio, Italy (enrolling)
- Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department — Ravenna, Italy (enrolling)
- MED-Polonia, Sp. z o.o. (LLC) — Poznan, Greater Poland Voivodeship, Poland (enrolling)
- Sf. Nectarie Oncology Center — Craiova, Dolj, Romania (enrolling)
- Clinica Polisano S.R.L — Sibiu, Sibiu County, Romania (enrolling)
- SC Oncomed SRL — Timișoara, Timiș County, Romania (enrolling)
- University Hospital of Jaen — Jaén, Andalusia, Spain (enrolling)
- Regional University Hospital of Malaga — Málaga, Andalusia, Spain (enrolling)
- University Hospital Virgen del Rocio (HUVR) — Seville, Andalusia, Spain (enrolling)
- Hospital Clinic of Barcelona — Barcelona, Catalonia, Spain (enrolling)
- University Hospital Complex of Santiago (CHUS) — Santiago de Compostela, Galicia, Spain (enrolling)
- University Hospital of Girona Dr. Josep Trueta — Girona, Girona, Spain (enrolling)
Full record on ClinicalTrials.gov
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