Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07246863

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

Led by CatalYm GmbH · Updated on 2026-04-21

131

Participants Needed

15

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Main

  • 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

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

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

Birmingham, Alabama, United States, 35294-3300

Not Yet Recruiting

2

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

3

Duke University Medical Center

Durham, North Carolina, United States, 27710

Not Yet Recruiting

4

Hospital Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730

Actively Recruiting

5

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

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

6

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

Bielefeld, North Rhine-Westphalia, Germany, 33611

Actively Recruiting

7

Clinics Essen-Mitte

Essen, North Rhine-Westphalia, Germany, 45136

Actively Recruiting

8

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

Forlì, Emilia-Romagna, Italy, 47014

Actively Recruiting

9

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

Ravenna, Italy, 48121

Actively Recruiting

10

University Hospital of Jaen

Jaén, Andalusia, Spain, 23007

Actively Recruiting

11

Regional University Hospital of Malaga

Málaga, Andalusia, Spain, 29010

Actively Recruiting

12

University Hospital 12 de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

13

University Hospital Lucus Augusti (HULA)

Lugo, Spain, 27003

Actively Recruiting

14

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

15

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, Switzerland, CH-9007

Actively Recruiting

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Research Team

L

Lena Lemke, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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