Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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