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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 Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer, sponsored by CatalYm.

Recruiting
Registry status
Phase 2
Development phase
131
Enrollment target
13
Study locations

NCT07246863 is a Phase 2 study of Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer that is actively recruiting participants, run by CatalYm. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 3 other Adult Solid Tumor trials with a reported enrollment target. The trial reports 13 study locations across 9 states.

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The verdict

NCT07246863, a Phase 2 study of Adult Solid Tumor and Metastatic Non-Squamous Non-Small Cell Lung Cancer, 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).

Conditions Studied

Adult Solid Tumor Metastatic Non-Squamous Non-Small Cell Lung Cancer

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

4 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, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 133-participant average among 3 other Adult Solid Tumor trials with a reported enrollment target. The listed sponsor is CatalYm, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT07246863 reports 13 study locations spanning 9 distinct geographic areas - top geographies include 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: Adult Solid Tumor, Metastatic Non-Squamous Non-Small Cell Lung Cancer.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.