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RecruitingInterventionalPhase 2

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)

NCT ID: NCT07246863Sponsor: CatalYm GmbHLast updated: 2026-06-09

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).

Arms & interventions

  • BiologicalVisugromab RDE (recommended dose for expansion)

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

  • BiologicalVisugromab 6mg/kg

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

  • BiologicalNivolumab

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

  • OtherPlacebo Saline Infusion

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

  • DrugDocetaxel

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

Outcome measures

Primary

  • Objective Response Rate (ORR)

    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

    Time frame: up to 36 months

Secondary

  • Adverse Events

    Time frame: up to 60 months

  • CR rate

    Time frame: up to 36 months

  • PR rate

    Time frame: up to 36 months

  • ORR rate

    Time frame: up to 36 months

  • DOR

    Time frame: up to 36 months

  • TTR

    Time frame: up to 36 months

  • PFS

    Time frame: up to 60 months

  • OS

    Time frame: up to 60 months

  • Participant weight course over time

    Time frame: up to 39 months

  • Maximum Concentration (Cmax) of visugromab

    Time frame: up to 36 months

  • Minimum Concentration (Cmin) visugromab

    Time frame: up to 36 months

  • Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    Time frame: up to 39 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

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

Birmingham, Alabama, 35294-3300

Recruiting
Leigh McManus, RN, MSHQS, CCRP · Contact

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

NYU Longone Health

New York, New York, 10016

Recruiting
Rajwanth Veluswamy, Dr · Contact

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting
Alicia Wilkerson · Contact