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RECRUITING Phase 2

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

NCT07246863 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 131 participants
Start Date 2025-10-07
Est. Completion 2031-10-01
Phase Phase 2

Sponsor

CatalYm

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07246863

The ClinicalTrials.gov registry entry for NCT07246863 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CatalYm, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Adult Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07246863 reports 13 study locations spanning 9 distinct geographic areas — top geographies include Other, North Rhine-Westphalia, Andalusia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Adult Solid Tumor, Metastatic Non-Squamous Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07246863?

This trial is sponsored by CatalYm, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial