Trials / Recruiting
RecruitingNCT07246863
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (estimated)
- Sponsor
- CatalYm GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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) 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Visugromab RDE (recommended dose for expansion) | Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
| BIOLOGICAL | Visugromab 6mg/kg | Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
| BIOLOGICAL | Nivolumab | Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
| OTHER | Placebo Saline Infusion | Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
| DRUG | Docetaxel | Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
Timeline
- Start date
- 2025-10-07
- Primary completion
- 2029-10-01
- Completion
- 2031-10-01
- First posted
- 2025-11-24
- Last updated
- 2026-03-04
Locations
13 sites across 5 countries: United States, Germany, Italy, Spain, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07246863. Inclusion in this directory is not an endorsement.