RECRUITING

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

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor CTL-002 Visugromab GDF-15

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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)

Quick Facts

Study Start:2025-08-01

Study Completion:2031-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07098988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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).	* 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 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.

Inclusion Criteria

Exclusion 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 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).

* 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 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.

Contacts and Locations

Study Contact

Felix Lichtenegger, MD

CONTACT

+49 89 200066440

regulatory-003@catalym.com

Gerda Vlasitz-Kocks

CONTACT

+49 89 200066440

regulatory-003@catalym.com

Principal Investigator

Felix Lichtenegger, MD

STUDY_DIRECTOR

CatalYm GmbH

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2936

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Yale Cancer Center

New Haven, Connecticut, 06519

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: CatalYm GmbH

Felix Lichtenegger, MD, STUDY_DIRECTOR, CatalYm GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2031-03-31

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2031-03-31

Terms related to this study

Keywords Provided by Researchers

CTL-002
Visugromab
GDF-15

Additional Relevant MeSH Terms

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