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Study identifier: NCT07246863 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

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

Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer · Adult Solid Tumor  ·  Sponsor: CatalYm GmbH

PhasePhase 2
Planned participants131
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Lena Lemke, MD  ·  +49 89 200066440  ·  regulatory-004@catalym.com

Always discuss trial participation with your own doctor first.

Locations (33)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)Birmingham, Alabama, United StatesRecruiting
USC Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
NYU Langone Hospital - Long IslandMineola, New York, United StatesRecruiting
NYU Longone HealthNew York, New York, United StatesRecruiting
Duke University Medical CenterDurham, North Carolina, United StatesRecruiting
Hospital Esslingen GmbHEsslingen am Neckar, Baden-Wurttemberg, GermanyRecruiting
Thorax Clinic HeidelbergHeidelberg, Baden-Wurttemberg, GermanyRecruiting
University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical ImmunologyWürzburg, Bavaria, GermanyRecruiting
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine JohannesstiftBielefeld, North Rhine-Westphalia, GermanyRecruiting
Clinics Essen-MitteEssen, North Rhine-Westphalia, GermanyRecruiting
Foundation Bethanien MoersMoers, North Rhine-Westphalia, GermanyRecruiting
Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRSTForlì, Emilia-Romagna, ItalyRecruiting

+ 21 more locations — full list on the registry record.

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