Actively Recruiting
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Led by CatalYm GmbH · Updated on 2026-05-13
107
Participants Needed
37
Research Sites
295 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) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 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 in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
- No actionable mutations requiring targeted therapy (e.g., EGFR, ALK).
- Measurable disease per RECIST v1.1 by local investigator.
- No prior systemic treatment for advanced/metastatic NSCLC, except completed adjuvant/neoadjuvant therapy at least 12 months before metastasis without PD-1/PD-L1 therapy.
- Availability of locally determined PD-L1 TPS from tumor biopsy after any prior systemic treatment.
- Availability of a tissue biopsy for translational research obtained after any prior systemic treatment, with signed informed consent; cytological samples not accepted.
- Age 18 years or older at consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate bone marrow, liver, kidney function, and coagulation.
You will not qualify if you...
- Predominantly squamous cell or neuroendocrine histology NSCLC, or small cell lung cancer elements.
- Acute or chronic major tissue injury requiring maintained GDF-15 function within 3 months before treatment.
- Major surgery within 4 weeks before first study drug dose.
- Curative lung radiation therapy >30 Gy within 6 months before first study drug dose.
- Focal radiotherapy for symptoms within 28 days before first study drug dose.
- Expected need for other antineoplastic therapy during trial.
- Clinically active inflammatory bowel disease, diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Prior malignancy unless disease-free for 5 years after curative therapy.
- Active CNS involvement by NSCLC or other tumors unless enrolled with mandatory brain imaging.
- Cardiovascular risk factors such as recent myocardial infarction, uncontrolled heart failure or arrhythmia, prolonged QT interval, recent peri/myocarditis, or recent ischemic stroke within 3 months.
- Active autoimmune disease requiring systemic treatment within 3 months before treatment.
- Use of metformin or metformin-containing antidiabetics in type II diabetes.
- Interstitial lung disease or history of non-infectious pneumonitis requiring steroids or current pneumonitis.
- Pregnancy, breastfeeding, or expecting to conceive or father children during the trial.
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Trial Site Locations
Total: 37 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2936
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
4
NYU Longone Health
New York, New York, United States, 10016
Actively Recruiting
5
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
Thorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69126
Actively Recruiting
8
University Hospital Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
9
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Bielefeld, North Rhine-Westphalia, Germany, 33611
Actively Recruiting
10
Clinics Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
11
Foundation Bethanien Moers
Moers, North Rhine-Westphalia, Germany, 47441
Actively Recruiting
12
Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology
Großhansdorf, Schleswig-Holstein, Germany, 22927
Actively Recruiting
13
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Meldola, Forli, Italy, 47014
Actively Recruiting
14
Oncology Reference Center
Aviano, Italy, 33081
Actively Recruiting
15
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, Italy, 48121
Actively Recruiting
16
National Cancer Institute Regina Elena, IRCCS
Rome, Italy, 00144
Actively Recruiting
17
MED-Polonia, Sp. z o.o. (LLC)
Poznan, Poland, 60-693
Actively Recruiting
18
Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology
Prabuty, Poland, 82-550
Actively Recruiting
19
"Sf. Nectarie" Oncology Center, Department of Medical Oncology
Craiova, Dolj, Romania, 200542
Actively Recruiting
20
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, Romania, 110283
Actively Recruiting
21
Clinica Polisano S.R.L.
Sibiu, Romania, 550253
Actively Recruiting
22
SC Oncomed SRL, Department of Medical Oncology
Timișoara, Romania, +40 () 727 774 974
Actively Recruiting
23
University Hospital of Jaen
Jaén, Andalusia, Spain, 23007
Actively Recruiting
24
Regional University Hospital of Malaga
Málaga, Andalusia, Spain, 29010
Actively Recruiting
25
University Hospital Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
26
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia, Spain, 41013
Actively Recruiting
27
University Hospital Marques de Valdecilla (HUMV)
Santander, Cantabria, Spain, 39008
Actively Recruiting
28
Hospital del Mar
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
29
University Clinic of Navarra - Pamplona
Pamplona, Chartered Community of Navarre, Spain, 31008
Actively Recruiting
30
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Galicia, Spain, 15706
Actively Recruiting
31
START- Rioja
Rioja, La Rioja, Spain, 26006
Actively Recruiting
32
University Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
33
University Hospital HM Sanchinarro
Madrid, Madrid, Spain, 28050
Actively Recruiting
34
University Hospital Lucus Augusti (HULA)
Lugo, Spain, 27003
Actively Recruiting
35
University Hospital Basel
Basel, Basel, Switzerland, 4031
Actively Recruiting
36
Fribourg Cantonal Hospital
Fribourg, Canton of Fribourg, Switzerland, 1708
Actively Recruiting
37
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
Research Team
F
Felix Lichtenegger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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