Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Condition(s) studied
Investigational drug(s) / intervention(s)
Visugromab: Participants receive Visugromab (recommended dose) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Matching placebo for visugromab: Participants receive Matching Placebo intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Pembrolizumab 200 mg Q3W: Participants receive Pembrolizumab 200 mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion.
Pemetrexed 500 mg/m^2: Participants receive Pemetrexed 500 mg/m\^2 IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Carboplatin AUC 5: Participants receive Carboplatin target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) on Day 1 of each 21-day cycle for four cycles.
Study 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
Primary outcome measure(s)
- Objective Response Rate — up to 24 months
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the core trial period
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| NYU Longone Health | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Thorax Clinic Heidelberg | Heidelberg | Baden-Wurttemberg | Recruiting |
| University Hospital Würzburg | Würzburg | Bavaria | Recruiting |
| Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift | Bielefeld | North Rhine-Westphalia | Recruiting |
| Clinics Essen-Mitte | Essen | North Rhine-Westphalia | Recruiting |
| Foundation Bethanien Moers | Moers | North Rhine-Westphalia | Recruiting |
| Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology | Großhansdorf | Schleswig-Holstein | Recruiting |
| Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST | Meldola | Forli | Recruiting |
| National Cancer Institute, IRCCS | Milan | Milan | Recruiting |
| Oncology Reference Center | Aviano | Italy | Recruiting |
| Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department | Ravenna | Italy | Recruiting |
| National Cancer Institute Regina Elena, IRCCS | Rome | Italy | Recruiting |
| MED-Polonia, Sp. z o.o. (LLC) | Poznan | Poland | Recruiting |
| Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology | Prabuty | Poland | Recruiting |
| "Sf. Nectarie" Oncology Center, Department of Medical Oncology | Craiova | Dolj | Recruiting |
| Gral Medical S.R.L. - Oncofort Hospital | Piteşti | Romania | Recruiting |
| Clinica Polisano S.R.L. | Sibiu | Romania | Recruiting |
| SC Oncomed SRL, Department of Medical Oncology | Timișoara | Romania | Recruiting |
| University Hospital of Jaen | Jaén | Andalusia | Recruiting |
| Regional University Hospital of Malaga | Málaga | Andalusia | Recruiting |
| University Hospital Virgen Macarena | Seville | Andalusia | Recruiting |
| University Hospital Virgen del Rocio (HUVR) | Seville | Andalusia | Recruiting |
| University Hospital Marques de Valdecilla (HUMV) | Santander | Cantabria | Recruiting |
| Hospital del Mar | Barcelona | Catalonia | Recruiting |
| Hospital Quiron Dexeus Barcelona | Barcelona | Catalonia | Recruiting |
| University Clinic of Navarra - Pamplona | Pamplona | Chartered Community of Navarre | Recruiting |
| University Hospital Complex of Santiago (CHUS) | Santiago de Compostela | Galicia | Recruiting |
| START- Rioja | Rioja | La Rioja | Recruiting |
| University Clinic of Navarra - Madrid | Madrid | Madrid | Recruiting |
| University Hospital 12 de Octubre | Madrid | Madrid | Recruiting |
| University Hospital HM Sanchinarro | Madrid | Madrid | Recruiting |
| University Hospital Lucus Augusti (HULA) | Lugo | Spain | Recruiting |
| MD Anderson International Cancer Center Spain | Madrid | Spain | Recruiting |
| University Hospital Basel | Basel | Basel | Recruiting |
+ 2 more sites — see the full list on the official registry below.
More CatalYm GmbH trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07098988 on ClinicalTrials.gov ↗ ← All trials in Italy