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NCT07246863PHASE2Recruiting

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

CatalYm GmbH

Start Date

10/7/2025

Completion Date

10/1/2031

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Visugromab RDE (recommended dose for expansion)

BIOLOGICAL

Visugromab 6mg/kg

BIOLOGICAL

Nivolumab

OTHER

Placebo Saline Infusion

DRUG

Docetaxel

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Conditions

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

Locations

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Birmingham, Alabama 35294-3300

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

NYU Longone Health

New York, New York 10016

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Hospital Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg 73730

Germany

Thorax Clinic Heidelberg

Heidelberg, Baden-Wurttemberg 69126

Germany

University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology

Würzburg, Bavaria 97080

Germany

Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift

Bielefeld, North Rhine-Westphalia 33611

Germany

Clinics Essen-Mitte

Essen, North Rhine-Westphalia 45136

Germany

Foundation Bethanien Moers

Moers, North Rhine-Westphalia 47441

Germany

Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST

Forlì, Emilia-Romagna 47014

Italy

Oncology Reference Center

Aviano, Friuli Venezia Giulia 33081

Italy

National Cancer Institute Regina Elena, IRCCS

Rome, Lazio 00144

Italy

Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department

Ravenna, 48121

Italy

MED-Polonia, Sp. z o.o. (LLC)

Poznan, Greater Poland Voivodeship 60693

Poland

Sf. Nectarie Oncology Center

Craiova, Dolj 200542

Romania

Clinica Polisano S.R.L

Sibiu, Sibiu County 55023

Romania

SC Oncomed SRL

Timișoara, Timiș County 300239

Romania

University Hospital of Jaen

Jaén, Andalusia 23007

Spain

Regional University Hospital of Malaga

Málaga, Andalusia 29010

Spain

University Hospital Virgen del Rocio (HUVR)

Seville, Andalusia 41013

Spain

Hospital Clinic of Barcelona

Barcelona, Catalonia 08036

Spain

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, Galicia 15706

Spain

University Hospital of Girona Dr. Josep Trueta

Girona, Girona 17007

Spain

START- Rioja

Logroño, La Rioja 26006

Spain

Clínica Universidad de Navarra

Madrid, Madrid 28027

Spain

University Hospital 12 de Octubre

Madrid, Madrid 28041

Spain

University Hospital HM Sanchinarro

Madrid, Madrid 28050

Spain

University Clinic of Navarra - Pamplona

Pamplona, Navarre 31008

Spain

University Hospital Lucus Augusti (HULA)

Lugo, 27003

Spain

University Hospital Basel

Basel, 4031

Switzerland

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, CH-9007

Switzerland