Recruiting
Phase 2

Visugromab & ICT

Sponsor:

CatalYm GmbH

Code:

NCT07098988

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Adult Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visugromab

Matching placebo for visugromab

Pembrolizumab 200 mg Q3W

Pemetrexed 500 mg/m^2

Carboplatin AUC 5

Study Details

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).

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Adult Solid Tumor

Study ID

NCT07098988

Start date

Aug 1, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

107 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Visugromab (CTL-002) + Immunochemotherapy Combination (SoC treatment) - Arm A

Participants receive Visugromab (recommended dose), Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles.

active comparator: Placebo + Immunochemotherapy Combination (SoC treatment) - Arm B

Participants receive matching placebo for visugromab, Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles.

Interventions

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.

Primary outcome measure

  • Objective Response Rate [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Felix Lichtenegger, MD

+49 89 200066440regulatory-003@catalym.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-2936

Contacts

Leigh McManus, RN, MSHQS, CCRP

205-934-4173lmcmanus@uabmc.edu

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sandy Tran

323-865-3935Sandy.Tran@med.usc.edu

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Sarah Goldberg, MD

203-785-7564sarah.goldberg@yale.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Anahid Aminpour

813-745-0287Anahid.Aminpour@moffitt.org

NYU Longone Health

Recruiting

New York, New York, United States, 10016

Contacts

Rajwanth Veluswamy, MD

212-731-5662rajwanth.veluswamy@nyulangone.org

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Alicia Wilkerson

919-681-4768Alicia.wilkerson@duke.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Meredith Hovart

843-792-2423Hovart@musc.edu

More Information

Sponsor

CatalYm GmbH

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • CTL-002
  • Visugromab
  • GDF-15

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CatalYm GmbH on 2026-08-10.