Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07246863 · ClinicalTrials.gov registry record · Phase 2
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L 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
- 131
- Enrollment target
- 13
- Study locations
NCT07246863: Recruiting Phase 2 study of Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, sponsored by CatalYm.
NCT07246863 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 131 participants, below the 277-participant average among 3 other Metastatic Non-Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (53% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07246863, 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
- 131 participants
- Enrollment target
- 13
- 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) 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).
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
- DRUG Docetaxel
- BIOLOGICAL Nivolumab
- BIOLOGICAL Visugromab RDE (recommended dose for expansion)
- BIOLOGICAL Visugromab 6mg/kg
- OTHER Placebo Saline Infusion
Study Locations (13)
Other
- University Hospital Lucus Augusti (HULA) - Lugo
- University Hospital Basel - Basel
- Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology - Sankt Gallen
North Rhine-Westphalia
- Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift - Bielefeld
- Clinics Essen-Mitte - Essen
Andalusia
- University Hospital of Jaen - Jaén
- Regional University Hospital of Malaga - Málaga
Alabama
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) - Birmingham
California
- USC Norris Comprehensive Cancer Center - Los Angeles
North Carolina
- Duke University Medical Center - Durham
Baden-Wurttemberg
- Hospital Esslingen GmbH - Esslingen am Neckar
Emilia-Romagna
- Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST - Forlì
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2031-10-01 |
| Phase | Phase 2 |
What NCT07246863 shows while recruiting
NCT07246863 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 3 other Metastatic Non-Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (53% 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 Docetaxel is the first listed.
NCT07246863 lists 13 locations in 9 states (Other, North Rhine-Westphalia, Andalusia).
Frequently Asked Questions
What is clinical trial NCT07246863 about?
NCT07246863 is a clinical study titled "Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L 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) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-plac...
What is the current status of trial NCT07246863?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2025-10-07. Estimated completion is 2031-10-01.
What conditions does trial NCT07246863 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 NCT07246863?
The interventions under investigation include: Docetaxel (DRUG), Nivolumab (BIOLOGICAL), Visugromab RDE (recommended dose for expansion) (BIOLOGICAL), Visugromab 6mg/kg (BIOLOGICAL), Placebo Saline Infusion (OTHER).
Who is sponsoring clinical trial NCT07246863?
This trial is sponsored by CatalYm, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07246863 being conducted?
This trial has 13 study locations across Alabama, California, North Carolina, Baden-Wurttemberg, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Non-Squamous Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
RECRUITING · Phase 2
-
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
RECRUITING · Phase 2
-
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03051464 · 131 participants · Phase 2
No Surgery Trial / Two Dose-escalation Strategies
- NCT04301843 · 131 participants · Phase 2
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
- NCT04748549 · 131 participants · NA
Intraoperative VR for Older Patients Undergoing TKA
- NCT05951179 · 131 participants · Phase 2
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI