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NCT07098988 | RECRUITING | Metastatic Non-Squamous Non-Small Cell Lung Cancer

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

CatalYm GmbH

Brief 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).

Condition or disease

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Adult Solid Tumor

Intervention/treatment

Visugromab

Matching placebo for visugromab

Pembrolizumab 200 mg Q3W

Pemetrexed 500 mg/m^2

Carboplatin AUC 5

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 107 participants
Masking : DOUBLE
Masking Description : Participants, Investigator and Site trial team, Sponsor and Service Providers' trial teams (including Imaging vendor) are blinded
Primary Purpose : TREATMENT
Official Title : A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)
Actual Study Start Date : 2025-08-01
Estimated Primary Completion Date : 2029-03-31
Estimated Study Completion Date : 2031-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

Location Details

NCT07098988

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, alabama

University of Alabama at Birmingham

Birmingham, alabama, United States, 35294-2936

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

ACTIVE NOT RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06519

NOT YET RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

ACTIVE NOT RECRUITING

Germany, Baden-Württemberg

Thorax Clinic Heidelberg

Heidelberg, Baden-Württemberg, Germany, 69126

ACTIVE NOT RECRUITING

Germany, Bavaria

University Hospital Würzburg

Würzburg, Bavaria, Germany, 97080

ACTIVE NOT RECRUITING

Germany, North Rhine-Westphalia

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

Bielefeld, North Rhine-Westphalia, Germany, 33611

RECRUITING

Germany, North Rhine-Westphalia

Clinics Essen-Mitte

Essen, North Rhine-Westphalia, Germany, 45136

RECRUITING

Germany, Schleswig-Holstein

Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology

Großhansdorf, Schleswig-Holstein, Germany, 22927

ACTIVE NOT RECRUITING

Italy, Forli

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

Meldola, Forli, Italy, 47014

RECRUITING

Italy,

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

Ravenna, Italy, 48121

ACTIVE NOT RECRUITING

Italy,

National Cancer Institute Regina Elena, IRCCS

Rome, Italy, 00144

RECRUITING

Romania, Dolj

"Sf. Nectarie" Oncology Center, Department of Medical Oncology

Craiova, Dolj, Romania, 200542

ACTIVE NOT RECRUITING

Romania,

Gral Medical S.R.L. - Oncofort Hospital

Pitesti, Romania, 110283

RECRUITING

Romania,

Polisano Clinic S.R.L.

Sibiu, Romania, 550253

RECRUITING

Romania,

SC Oncomed SRL, Department of Medical Oncology

Timisoara, Romania, +40 () 727 774 974

NOT YET RECRUITING

Spain, Andalusia

University Hospital of Jaen

Jaen, Andalusia, Spain, 23007

RECRUITING

Spain, Andalusia

Regional University Hospital of Malaga

Málaga, Andalusia, Spain, 29010

ACTIVE NOT RECRUITING

Spain, Andalusia

University Hospital Virgen Macarena

Seville, Andalusia, Spain, 41009

RECRUITING

Spain, Galicia

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, Galicia, Spain, 15706

ACTIVE NOT RECRUITING

Spain, Madrid

University Hospital October 12

Madrid, Madrid, Spain, 28041

RECRUITING

Spain,

University Hospital Lucus Augusti (HULA)

Lugo, Spain, 27003

RECRUITING

Switzerland, Basel

University Hospital Basel

Basel, Basel, Switzerland, 4031

ACTIVE NOT RECRUITING

Switzerland, Canton of Fribourg

Friborg Cantonal Hospital

Freiburg, Canton of Fribourg, Switzerland, 1708

RECRUITING

Switzerland, Canton of St. Gallen

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Saint Gallen, Canton of St. Gallen, Switzerland, 9007