NCT07246863Recruiting
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
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) 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).
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, Germany, Italy, United States, Poland, Romania, Spain
- Sponsor
- CatalYm GmbH(Industry)
- Protocol no.
- CTL-002-004
- Conditions
- Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
- Interventions
- Biological, Other, Drug
Treatments studied
- Visugromab RDE (recommended dose for expansion)
- Visugromab 6mg/kg
- Nivolumab
- Placebo Saline Infusion
- Docetaxel
Locations · 36
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Sankt Gallen, SwitzerlandCantonal Hospital Saint Gallen, Clinic of Oncology and HematologyRecruiting at this site
- Esslingen am Neckar, GermanyHospital Esslingen GmbHRecruiting at this site
- Heidelberg, GermanyThorax Clinic HeidelbergRecruiting at this site
- Würzburg, GermanyUniversity Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical ImmunologyRecruiting at this site
- Bielefeld, GermanyEvangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine JohannesstiftRecruiting at this site
- Essen, GermanyClinics Essen-MitteRecruiting at this site
- Moers, GermanyFoundation Bethanien MoersRecruiting at this site
- Forlì, ItalyInstitute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRSTRecruiting at this site
- Aviano, ItalyOncology Reference CenterRecruiting at this site
- Rome, ItalyNational Cancer Institute Regina Elena, IRCCSRecruiting at this site
- Milan, ItalyEuropean Institute of Oncology (IEO), IRCCSRecruiting at this site
- Candiolo, ItalyInstitute of Cancer Research and Treatment of CandioloRecruiting at this site
- Ravenna, ItalyLocal Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology DepartmentRecruiting at this site
- Birmingham, United StatesUniversity of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)Recruiting at this site
- Los Angeles, United StatesUSC Norris Comprehensive Cancer CenterRecruiting at this site
- Mineola, United StatesNYU Langone Hospital - Long IslandRecruiting at this site
- New York, United StatesNYU Longone HealthRecruiting at this site
- Durham, United StatesDuke University Medical CenterRecruiting at this site
- Poznan, PolandMED-Polonia, Sp. z o.o. (LLC)Recruiting at this site
- Craiova, RomaniaSf. Nectarie Oncology CenterRecruiting at this site
- Sibiu, RomaniaClinica Polisano S.R.LRecruiting at this site
- Timișoara, RomaniaSC Oncomed SRLRecruiting at this site
- Jaén, SpainUniversity Hospital of JaenRecruiting at this site
- Málaga, SpainRegional University Hospital of MalagaRecruiting at this site
- Seville, SpainUniversity Hospital Virgen del Rocio (HUVR)Recruiting at this site
- Barcelona, SpainHospital Quiron Dexeus BarcelonaRecruiting at this site
- Barcelona, SpainHospital Clinic of BarcelonaRecruiting at this site
- Santiago de Compostela, SpainUniversity Hospital Complex of Santiago (CHUS)Recruiting at this site
- Girona, SpainUniversity Hospital of Girona Dr. Josep TruetaRecruiting at this site
In total, worldwide, all 36 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 26, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 6 more locations
Other identifiers
- 2024-516794-70-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.