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Clinical Trials in Germany / NCT07098988
Recruiting Phase 2

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

NCT07098988 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2025-08-01
Last updated
2026-08-10

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Visugromab →Matching placebo for visugromabPembrolizumab 200 mg Q3W →Pemetrexed 500 mg/m^2 →Carboplatin AUC 5 →

Visugromab: Participants receive Visugromab (recommended dose) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

Matching placebo for visugromab: Participants receive Matching Placebo intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

Pembrolizumab 200 mg Q3W: Participants receive Pembrolizumab 200 mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion.

Pemetrexed 500 mg/m^2: Participants receive Pemetrexed 500 mg/m\^2 IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.

Carboplatin AUC 5: Participants receive Carboplatin target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) on Day 1 of each 21-day cycle for four cycles.

Study 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) 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Main Inclusion Criteria: * Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC. * Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent. * Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1. * Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy. * Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated. * Availability of a tissue/histological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted. * Age ≥ 18 years on the day of signing the informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: * Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage). * Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \< 3 months prior to planned treatment start). * Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug. * Received potentially curative radiation therapy to the lung that is \> 30 Gy within 6 months prior to the first dose of study drug. * Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug. * Expected to require any other form of antineoplastic therapy while on trial. * Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction. * Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * 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 with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions. * Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri/myocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start. * Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes. * Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
NYU Longone Health New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Thorax Clinic Heidelberg Heidelberg Baden-Wurttemberg Recruiting
University Hospital Würzburg Würzburg Bavaria Recruiting
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift Bielefeld North Rhine-Westphalia Recruiting
Clinics Essen-Mitte Essen North Rhine-Westphalia Recruiting
Foundation Bethanien Moers Moers North Rhine-Westphalia Recruiting
Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology Großhansdorf Schleswig-Holstein Recruiting
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST Meldola Forli Recruiting
National Cancer Institute, IRCCS Milan Milan Recruiting
Oncology Reference Center Aviano Italy Recruiting
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department Ravenna Italy Recruiting
National Cancer Institute Regina Elena, IRCCS Rome Italy Recruiting
MED-Polonia, Sp. z o.o. (LLC) Poznan Poland Recruiting
Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology Prabuty Poland Recruiting
"Sf. Nectarie" Oncology Center, Department of Medical Oncology Craiova Dolj Recruiting
Gral Medical S.R.L. - Oncofort Hospital Piteşti Romania Recruiting
Clinica Polisano S.R.L. Sibiu Romania Recruiting
SC Oncomed SRL, Department of Medical Oncology Timișoara Romania Recruiting
University Hospital of Jaen Jaén Andalusia Recruiting
Regional University Hospital of Malaga Málaga Andalusia Recruiting
University Hospital Virgen Macarena Seville Andalusia Recruiting
University Hospital Virgen del Rocio (HUVR) Seville Andalusia Recruiting
University Hospital Marques de Valdecilla (HUMV) Santander Cantabria Recruiting
Hospital del Mar Barcelona Catalonia Recruiting
Hospital Quiron Dexeus Barcelona Barcelona Catalonia Recruiting
University Clinic of Navarra - Pamplona Pamplona Chartered Community of Navarre Recruiting
University Hospital Complex of Santiago (CHUS) Santiago de Compostela Galicia Recruiting
START- Rioja Rioja La Rioja Recruiting
University Clinic of Navarra - Madrid Madrid Madrid Recruiting
University Hospital 12 de Octubre Madrid Madrid Recruiting
University Hospital HM Sanchinarro Madrid Madrid Recruiting
University Hospital Lucus Augusti (HULA) Lugo Spain Recruiting
MD Anderson International Cancer Center Spain Madrid Spain Recruiting
University Hospital Basel Basel Basel Recruiting

+ 2 more sites — see the full list on the official registry below.

More CatalYm GmbH trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07098988 on ClinicalTrials.gov ↗ ← All trials in Germany