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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: CatalYm GmbH • ClinicalTrials.gov ID: NCT07098988

Registry updated: 2026-10-19
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Description

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).

Interventions

  • Visugromab (Biological)
    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 (Drug)
    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 (Biological)
    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 (Drug)
    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 (Drug)
    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.

Eligibility criteria

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.

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • Smilow Cancer Center, Derby — Derby, Connecticut, United States
  • Smilow Cancer Center, Guilford — Guilford, Connecticut, United States
  • Yale Cancer Center — New Haven, Connecticut, United States
  • Smilow Cancer Hospital - North Haven — North Haven, Connecticut, United States
  • Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital - Waterbury — Waterbury, Connecticut, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • NYU Longone Health — New York, New York, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Thorax Clinic Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
  • University Hospital Würzburg — Würzburg, Bavaria, Germany
  • Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift — Bielefeld, North Rhine-Westphalia, Germany
  • Clinics Essen-Mitte — Essen, North Rhine-Westphalia, Germany
  • Foundation Bethanien Moers — Moers, North Rhine-Westphalia, Germany
  • Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology — Großhansdorf, Schleswig-Holstein, Germany
  • Institute of Cancer Research and Treatment of Candiolo — Candiolo, Candiolo, Italy
  • Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST — Meldola, Forli, Italy
  • National Cancer Institute, IRCCS — Milan, Milan, Italy
  • Oncology Reference Center — Aviano, Italy
  • Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department — Ravenna, Italy
  • National Cancer Institute Regina Elena, IRCCS — Rome, Italy
  • University Teaching Hospital No. 4 in Lublin, Multi-Profile Non-Invasive Treatment Department — Lublin, Lublin Voivodeship, Poland
  • MED-Polonia, Sp. z o.o. (LLC) — Poznan, Poland
  • Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology — Prabuty, Poland
  • "Sf. Nectarie" Oncology Center, Department of Medical Oncology — Craiova, Dolj, Romania
  • Gral Medical S.R.L. - Oncofort Hospital — Piteşti, Romania
  • Clinica Polisano S.R.L. — Sibiu, Romania
  • SC Oncomed SRL, Department of Medical Oncology — Timișoara, Romania
  • University Hospital of Jaen — Jaén, Andalusia, Spain
  • Regional University Hospital of Malaga — Málaga, Andalusia, Spain
  • University Hospital Virgen Macarena — Seville, Andalusia, Spain
  • University Hospital Virgen del Rocio (HUVR) — Seville, Andalusia, Spain
  • University Hospital Marques de Valdecilla (HUMV) — Santander, Cantabria, Spain
  • Hospital del Mar — Barcelona, Catalonia, Spain
  • Hospital Quiron Dexeus Barcelona — Barcelona, Catalonia, Spain
  • University Clinic of Navarra - Pamplona — Pamplona, Chartered Community of Navarre, Spain
  • University Hospital Complex of Santiago (CHUS) — Santiago de Compostela, Galicia, Spain
  • Catalan Institute of Oncology of Girona — Girona, Girona, Spain
  • START- Rioja — Rioja, La Rioja, Spain
  • University Clinic of Navarra - Madrid — Madrid, Madrid, Spain
  • University Hospital 12 de Octubre — Madrid, Madrid, Spain
  • University Hospital HM Sanchinarro — Madrid, Madrid, Spain
  • University Hospital Lucus Augusti (HULA) — Lugo, Spain
  • MD Anderson International Cancer Center Spain — Madrid, Spain
  • University Hospital Basel — Basel, Basel, Switzerland
  • Fribourg Cantonal Hospital — Fribourg, Canton of Fribourg, Switzerland
  • Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology — Sankt Gallen, Canton of St. Gallen, Switzerland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record