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

NCT07246863 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CTL-002-0042024-516794-70-00
• Study Type: interventional
• Target: 131
• Locations: 5 countries
• Sites: 15

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

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

Keywords

CTL-002; Visugromab; GDF-15

Outcome Measures

Primary Outcomes (1)

• 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

  up to 36 months

Secondary Outcomes (12)

• Adverse Events

  up to 60 months

• CR rate

  up to 36 months

• PR rate

  up to 36 months

• ORR rate

  up to 36 months

• DOR

  up to 36 months

Study Arms (4)

Arm A

EXPERIMENTAL

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

Biological: Visugromab RDE (recommended dose for expansion); Biological: Nivolumab; Drug: Docetaxel

Arm B

EXPERIMENTAL

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

Biological: Visugromab 6mg/kg; Biological: Nivolumab; Drug: Docetaxel

Arm C

EXPERIMENTAL

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

Biological: Visugromab RDE (recommended dose for expansion); Biological: Nivolumab

Arm D

ACTIVE COMPARATOR

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

Other: Placebo Saline Infusion; Drug: Docetaxel

Interventions

Visugromab 6mg/kg BIOLOGICAL

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

Also known as: CTL-002

Arm B

Nivolumab BIOLOGICAL

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

Also known as: OPDIVO®

Arm A; Arm B; Arm C

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)

Also known as: CTL-002

Arm A; Arm C

Placebo Saline Infusion OTHER

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

Also known as: 0.9% NaCl

Arm D

Docetaxel DRUG

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

Arm A; Arm B; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CatalYm GmbH: lead

Study Sites (15)

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

Birmingham, Alabama, 35294-3300, United States

NOT YET RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Hospital Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

RECRUITING

University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology

Würzburg, Bavaria, 97080, Germany

RECRUITING

Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift

Bielefeld, North Rhine-Westphalia, 33611, Germany

RECRUITING

Clinics Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST

Forlì, Emilia-Romagna, 47014, Italy

RECRUITING

Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department

Ravenna, 48121, Italy

RECRUITING

University Hospital of Jaen

Jaén, Andalusia, 23007, Spain

RECRUITING

Regional University Hospital of Malaga

Málaga, Andalusia, 29010, Spain

RECRUITING

University Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

University Hospital Lucus Augusti (HULA)

Lugo, 27003, Spain

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, CH-9007, Switzerland

RECRUITING

MeSH Terms

Interventions

Nivolumab; Saline Solution; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lena Lemke, MD

  CatalYm GmbH

  STUDY DIRECTOR

Central Study Contacts

Lena Lemke, MD

CONTACT

+49 89 200066440; regulatory-004@catalym.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Throughout the randomized part of the trial, participants, Investigators, trial-assigned site staff (except for the pharmacists), the CRO (except for the unblinded clinical monitoring team), and imaging vendor will remain blinded to the information of which participant is receiving which IMP in Treatment Arms A, B and D, treatment assignment to the chemotherapy-free Arm C will be open label. Sponsor staff may be unblinded on an as needed basis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Safety Run-In Part B and C: Randomized Part consists of 4 Arms: Arm A: Visugromab at the recommended dose for expansion (RDE) with Nivolumab and Docetaxel, Arm B: Visugromab 6 mg/kg with Nivolumab and Docetaxel, Arm C: Visugromab at the RDE with Nivolumab Arm D: Double Placebo (saline) and Docetaxel Participants will be allocated in 2:1:1:1 ratio to treatment arms A, B, C, or D

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 24, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); US (3); CH (2); DE (4); IT (2)