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NCT07098988 · ClinicalTrials.gov registry record · Phase 2
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
A Phase 2 study of Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer, sponsored by CatalYm.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT07098988 is a Phase 2 study of Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer that is actively recruiting participants, run by CatalYm. The registered enrollment target is 107 participants, below the 141-participant average among 3 other Adult Solid Tumor trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT07098988, a Phase 2 study of Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by CatalYm.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2031-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 3 other Adult Solid Tumor trials with a reported enrollment target (24% lower). The listed sponsor is CatalYm, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT07098988 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Andalusia, North Rhine-Westphalia.
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.
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).
Who is sponsoring clinical trial NCT07098988?
This trial is sponsored by CatalYm, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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