Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Public ClinicalTrials.gov record NCT07098988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07098988
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 107 participants
Conditions and interventions
Interventions
- Visugromab Biological
- Matching placebo for visugromab Drug
- Pembrolizumab 200 mg Q3W Biological
- Pemetrexed 500 mg/m^2 Drug
- Carboplatin AUC 5 Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2025
- Primary completion
- Mar 30, 2029
- Completion
- Mar 30, 2031
- Last update posted
- Aug 9, 2026
2025 – 2031
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-2936 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06519 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| NYU Longone Health | New York | New York | 10016 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07098988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07098988 live on ClinicalTrials.gov.