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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 Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, sponsored by CatalYm.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT07098988: Recruiting Phase 2 study of Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, sponsored by CatalYm.
NCT07098988 is a Phase 2 study of Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor that is actively recruiting participants, run by CatalYm. The registered enrollment target is 107 participants, below the 285-participant average among 3 other Metastatic Non-Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07098988, a Phase 2 study of Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, 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).
Primary Outcome
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the core trial period
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 |
What NCT07098988 shows while recruiting
NCT07098988 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 285-participant average among 3 other Metastatic Non-Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Metastatic Non-Squamous Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Visugromab is the first listed.
NCT07098988 names 20 study sites across 13 states, led by 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: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor.
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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