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RECRUITING Phase 2

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

NCT07098988 · View on ClinicalTrials.gov ↗

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).

Interventions

  • BIOLOGICAL Visugromab
  • DRUG Matching placebo for visugromab
  • BIOLOGICAL Pembrolizumab 200 mg Q3W
  • DRUG Pemetrexed 500 mg/m^2
  • DRUG Carboplatin AUC 5

Study Locations (20)

Other

  • Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department — Ravenna
  • National Cancer Institute Regina Elena, IRCCS — Rome
  • Gral Medical S.R.L. - Oncofort Hospital — Piteşti
  • Clinica Polisano S.R.L. — Sibiu
  • SC Oncomed SRL, Department of Medical Oncology — Timișoara

Andalusia

  • University Hospital of Jaen — Jaén
  • Regional University Hospital of Malaga — Málaga
  • University Hospital Virgen Macarena — Seville

North Rhine-Westphalia

  • Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift — Bielefeld
  • Clinics Essen-Mitte — Essen

Alabama

  • University of Alabama at Birmingham — Birmingham

California

  • USC Norris Comprehensive Cancer Center — Los Angeles

Connecticut

  • Yale Cancer Center — New Haven

North Carolina

  • Duke University Medical Center — Durham

Baden-Wurttemberg

  • Thorax Clinic Heidelberg — Heidelberg

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2025-08-01
Est. Completion 2031-03-31
Phase Phase 2

Sponsor

CatalYm

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07098988

The ClinicalTrials.gov registry entry for NCT07098988 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CatalYm, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Adult Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Visugromab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07098988 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Andalusia, North Rhine-Westphalia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07098988 about?

NCT07098988 is a clinical study titled "Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC". 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 wit...

What is the current status of trial NCT07098988?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2025-08-01. Estimated completion is 2031-03-31.

What conditions does trial NCT07098988 study?

This clinical trial studies the following conditions: Adult Solid Tumor, Metastatic Non-Squamous Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07098988?

The interventions under investigation include: Visugromab (BIOLOGICAL), Matching placebo for visugromab (DRUG), Pembrolizumab 200 mg Q3W (BIOLOGICAL), Pemetrexed 500 mg/m^2 (DRUG), Carboplatin AUC 5 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07098988?

This trial is sponsored by CatalYm, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07098988 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, North Carolina, Baden-Wurttemberg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial