Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

NCT07246863 · tracked via the Priya Life Science USA tracker

Sponsor

CatalYm GmbH

Phase

Phase 2

Started

2025-10-07

Last updated

2026-08-19

Condition(s) studied

Metastatic Non-Squamous Non-Small Cell Lung CancerAdult Solid Tumor

Investigational drug(s) / intervention(s)

Visugromab RDE (recommended dose for expansion)Visugromab 6mg/kgNivolumabPlacebo Saline InfusionDocetaxel

Visugromab RDE (recommended dose for expansion): Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Visugromab 6mg/kg: Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Nivolumab: Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Placebo Saline Infusion: Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Docetaxel: Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

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) 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Main 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.

Primary outcome measure(s)

Objective Response Rate (ORR) — up to 36 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 (34)

Facility	City	Region	Status
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)	Birmingham	Alabama	Recruiting
USC Norris Comprehensive Cancer Center	Los Angeles	California	Recruiting
NYU Langone Hospital - Long Island	Mineola	New York	Recruiting
NYU Longone Health	New York	New York	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Hospital Esslingen GmbH	Esslingen am Neckar	Baden-Wurttemberg	Recruiting
Thorax Clinic Heidelberg	Heidelberg	Baden-Wurttemberg	Recruiting
University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology	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
Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST	Forlì	Emilia-Romagna	Recruiting
Oncology Reference Center	Aviano	Friuli Venezia Giulia	Recruiting
National Cancer Institute Regina Elena, IRCCS	Rome	Lazio	Recruiting
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department	Ravenna	Italy	Recruiting
MED-Polonia, Sp. z o.o. (LLC)	Poznan	Greater Poland Voivodeship	Recruiting
Sf. Nectarie Oncology Center	Craiova	Dolj	Recruiting
Clinica Polisano S.R.L	Sibiu	Sibiu County	Recruiting
SC Oncomed SRL	Timișoara	Timiș County	Recruiting
University Hospital of Jaen	Jaén	Andalusia	Recruiting
Regional University Hospital of Malaga	Málaga	Andalusia	Recruiting
University Hospital Virgen del Rocio (HUVR)	Seville	Andalusia	Recruiting
Hospital Quiron Dexeus Barcelona	Barcelona	Barcelona	Recruiting
Hospital Clinic of Barcelona	Barcelona	Catalonia	Recruiting
University Hospital Complex of Santiago (CHUS)	Santiago de Compostela	Galicia	Recruiting
University Hospital of Girona Dr. Josep Trueta	Girona	Girona	Recruiting
START- Rioja	Logroño	La Rioja	Recruiting
Clínica Universidad de Navarra	Madrid	Madrid	Recruiting
University Hospital 12 de Octubre	Madrid	Madrid	Recruiting
University Hospital HM Sanchinarro	Madrid	Madrid	Recruiting
University Clinic of Navarra - Pamplona	Pamplona	Navarre	Recruiting
University Hospital Lucus Augusti (HULA)	Lugo	Spain	Recruiting
University Hospital Basel	Basel	Switzerland	Recruiting
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology	Sankt Gallen	Switzerland	Recruiting

Official registry record

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 NCT07246863 on ClinicalTrials.gov ↗ ← All trials in the USA