Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
NCT ID: NCT07246863
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
131 participants
INTERVENTIONAL
2025-10-07
2031-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
NCT07098988
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
NCT04623775
Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer
NCT02639234
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
NCT03770299
A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
NCT04151563
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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 and Placebo (saline),
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
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Nivolumab
Participants receive Nivolumab 360mg 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)
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)
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)
Nivolumab
Participants receive Nivolumab 360mg 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)
Visugromab 6mg/kg
Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Arm C
Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (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)
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)
Arm D
Double Placebo (Saline) + Docetaxel (75 mg/m2), 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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CatalYm GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lena Lemke, MD
Role: STUDY_DIRECTOR
CatalYm GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospital of Jaen
Jaén, Andalusia, Spain
University Hospital Basel
Basel, , Switzerland
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-516794-70-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTL-002-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.