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Clinical Trials in Italy / NCT07246863
Recruiting Phase 2

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

NCT07246863 · tracked via the Priya Life Science Italy 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/kg →Nivolumab →Placebo 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
No
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)

FacilityCityRegionStatus
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

On this site

📄 Opdivo (nivolumab) drug profile →

More CatalYm GmbH trials in Italy

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC Recruiting
Visugromab in Cachexia International Trial Recruiting
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure Recruiting

Other trials for the same condition

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC 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 Italy