Recruiting
Phase 2

Visugromab & Nivolumab

Sponsor:

CatalYm GmbH

Code:

NCT07246863

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Adult Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visugromab RDE (recommended dose for expansion)

Visugromab 6mg/kg

Nivolumab

Placebo Saline Infusion

Docetaxel

Study Details

Brief 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

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Adult Solid Tumor

Study ID

NCT07246863

Start date

Oct 7, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2031

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Main Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
  • Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
  • Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.
  • Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
  • Participants must have life expectancy of at least 3 months as assessed by the Investigator.
  • Participants must have ECOG performance status ≤1.

Main Exclusion Criteria:

  • Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
  • Participants must not have a prior malignancy requiring treatment.
  • Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis
  • Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

Study Design

Enrollment

131 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Visugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

experimental: Arm B

Visugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

experimental: Arm C

Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

active comparator: Arm D

Double Placebo (Saline) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Interventions

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)

Visugromab 6mg/kg

Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Nivolumab

Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Placebo Saline Infusion

Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Docetaxel

Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Primary outcome measure

  • Objective Response Rate (ORR) [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

Lena Lemke, MD

+49 89 200066440regulatory-004@catalym.com

Locations

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Recruiting

Birmingham, Alabama, United States, 35294-3300

Contacts

Leigh McManus, RN, MSHQS, CCRP

205-934-4173lmcmanus@uabmc.edu

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sandy Tran

323-865-3935Sandy.Tran@med.usc.edu

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Rajwanth Veluswamy, Dr

212-731-5662rajwanth.veluswamy@nyulangone.org

David Mangar

212-404-3628david.mangar@nyulangone.org

NYU Longone Health

Recruiting

New York, New York, United States, 10016

Contacts

Rajwanth Veluswamy, Dr

212-731-5662rajwanth.veluswamy@nyulangone.org

David Mangar

212-404-3628david.mangar@nyulangone.org

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Alicia Wilkerson

919-681-4768Alicia.wilkerson@duke.edu

More Information

Sponsor

CatalYm GmbH

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • CTL-002
  • Visugromab
  • GDF-15

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CatalYm GmbH on 2026-08-19.