Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Recruiting · NCT07246863 · Interventional (participants receive a specific treatment) · Lead sponsor: CatalYm GmbH
View the official record on ClinicalTrials.gov →Interventions studied
DocetaxelNivolumabPlacebo Saline InfusionVisugromab 6mg/kgVisugromab RDE (recommended dose for expansion)
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
- Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.
- Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
- Participants must have life expectancy of at least 3 months as assessed by the Investigator.
- Participants must have ECOG performance status ≤1.
- Main
Exclusion criteria
- Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
- Participants must not have a prior malignancy requiring treatment.
- Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis
- Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
Where it is running
34 locations listed across 4 US states.
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) - Birmingham, Alabama, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- NYU Langone Hospital - Long Island - Mineola, New York, United States
- NYU Longone Health - New York, New York, United States
- Duke University Medical Center - Durham, North Carolina, United States
- University Hospital Basel - Basel, Switzerland
- University Hospital Lucus Augusti (HULA) - Lugo, Spain
- Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department - Ravenna, Italy
- Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology - Sankt Gallen, Switzerland
- University Hospital of Jaen - Jaén, Andalusia, Spain
- Regional University Hospital of Malaga - Málaga, Andalusia, Spain
- University Hospital Virgen del Rocio (HUVR) - Seville, Andalusia, Spain
- Hospital Esslingen GmbH - Esslingen am Neckar, Baden-Wurttemberg, Germany
- Thorax Clinic Heidelberg - Heidelberg, Baden-Wurttemberg, Germany
- Hospital Quiron Dexeus Barcelona - Barcelona, Barcelona, Spain
- 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
- Hospital Clinic of Barcelona - Barcelona, Catalonia, Spain
- Sf. Nectarie Oncology Center - Craiova, Dolj, Romania
- Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST - Forlì, Emilia-Romagna, Italy
- Oncology Reference Center - Aviano, Friuli Venezia Giulia, Italy
- University Hospital Complex of Santiago (CHUS) - Santiago de Compostela, Galicia, Spain
- University Hospital of Girona Dr. Josep Trueta - Girona, Girona, Spain
- MED-Polonia, Sp. z o.o. (LLC) - Poznan, Greater Poland Voivodeship, Poland
- START- Rioja - Logroño, La Rioja, Spain
- National Cancer Institute Regina Elena, IRCCS - Rome, Lazio, Italy
- Clínica Universidad de Navarra - Madrid, Madrid, Spain
- University Hospital 12 de Octubre - Madrid, Madrid, Spain
- University Hospital HM Sanchinarro - Madrid, Madrid, Spain
- University Clinic of Navarra - Pamplona - Pamplona, Navarre, Spain
- Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift - Bielefeld, North Rhine-Westphalia, Germany
- Clinics Essen-Mitte - Essen, North Rhine-Westphalia, Germany
- Foundation Bethanien Moers - Moers, North Rhine-Westphalia, Germany
- Clinica Polisano S.R.L - Sibiu, Sibiu County, Romania
- SC Oncomed SRL - Timișoara, Timiș County, Romania