Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Public ClinicalTrials.gov record NCT07246863. 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
Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)
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) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 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
- NCT07246863
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 131 participants
Conditions and interventions
Interventions
- Visugromab RDE (recommended dose for expansion) Biological
- Visugromab 6mg/kg Biological
- Nivolumab Biological
- Placebo Saline Infusion Other
- Docetaxel Drug
Biological · Other · 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
- Oct 6, 2025
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2031
- Last update posted
- Aug 18, 2026
2025 – 2031
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) | Birmingham | Alabama | 35294-3300 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | Recruiting |
| NYU Longone Health | New York | New York | 10016 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | 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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07246863, 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 18, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07246863 live on ClinicalTrials.gov.