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NCT Number: NCT07246863

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-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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Esslingen GmbH, Esslingen am Neckar, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visugromab RDE (recommended dose for expansion)

Biological

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

Other names: CTL-002

Visugromab 6mg/kg

Biological

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

Other names: CTL-002

Nivolumab

Biological

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

Other names: OPDIVO®

Placebo Saline Infusion

Other

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

Other names: 0.9% NaCl

docetaxel

Drug

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

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 36 months

    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

Secondary outcomes

  1. Adverse Events

    Time frame: up to 60 months

    Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events

  2. CR rate

    Time frame: up to 36 months

    Complete response rate

  3. PR rate

    Time frame: up to 36 months

    Partial response rate

  4. ORR rate

    Time frame: up to 36 months

    Overall response rate

  5. DOR

    Time frame: up to 36 months

    Duration of response

  6. TTR

    Time frame: up to 36 months

    Time-to-respond

  7. PFS

    Time frame: up to 60 months

    Progression-free survival

  8. OS

    Time frame: up to 60 months

    Overall survival

  9. Participant weight course over time

    Time frame: up to 39 months

    Participant weight course over time

  10. Maximum Concentration (Cmax) of visugromab

    Time frame: up to 36 months

    Cmax is the maximum observed serum concentration of visugromab.

  11. Minimum Concentration (Cmin) visugromab

    Time frame: up to 36 months

    Cmin is the minimum observed serum concentration of visugromab

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

    Time frame: up to 39 months

    NSCLC-SAQ is a participant reported outcome with seven (7) items assessing five (5) symptom domains of NSCLC: cough, fatigue, pain, dyspnea, and appetite. Each item is scored individually from 0 ("None/Never") to 4 ("Severe/Always").

    The total score is calculated by summing domain scores, which are derived as follows: single-item domains (cough, dyspnea, appetite) use the item score; fatigue uses the mean of two items (or one if only one is answered); pain uses the highest score of two items (or one if only one is answered). The total score ranges from 0-20, with higher scores indicating more severe symptoms. If any domain score is missing, a total score is not computed

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Lemke, MD

CONTACT

[email protected]

+49 89 200066440

Sponsors and collaborators

Lead sponsor

CatalYm GmbH

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Nov 24, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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