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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

anti-GDF-15 monoclonal antibody CTL-002. A humanized, hinge-stabilized immunoglobulin G4 (IgG4) monoclonal antibody directed against growth/differentiation factor 15 (GDF-15; macrophage inhibitory cytokine-1; MIC-1; non-steroidal anti-inflammatory drug-inducible gene-1; NAG-1; placental transforming growth factor-beta; pTGFB; prostate-derived factor; PDF; placental bone morphogenetic protein; PLAB), with potential antineoplastic activity. Upon administration, anti-GDF-15 monoclonal antibody CTL-002 specifically targets, binds to and inhibits the activity of GDF-15, which may include its inhibition of lymphocyte function-associated antigen 1 (LFA-1) activation on CD8+ T cells. This may restore immune cell infiltration into the tumor, leading to tumor cell killing and inhibition of tumor cell proliferation. GDF-15, a divergent member of the transforming growth factor-beta (TGF-beta) superfamily of cytokines, is upregulated in tissue injuries and also secreted by various tumors. It has been linked to immunosuppression in the tumor microenvironment (TME) and is associated with drug resistance and poor prognosis. NCI Drug Dictionary

Treatments listed in the registry

• 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)
• Visugromab 6mg/kg (Biological): Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Nivolumab (Biological): Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Placebo Saline Infusion (Other): Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Docetaxel (Drug): Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Randomized · Parallel · masking: Double

Main goals

• Objective Response Rate (ORR) (up to 36 months)

Other goals

• Adverse Events
• CR rate
• PR rate
• ORR rate
• DOR
• TTR
• PFS
• OS
• Participant weight course over time
• Maximum Concentration (Cmax) of visugromab
• Minimum Concentration (Cmin) visugromab
• Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

Planned enrollment: 131 (estimated).

• University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center), Birmingham, Alabama
• USC Norris Comprehensive Cancer Center, Los Angeles, California
• NYU Langone Hospital - Long Island, Mineola, New York
• NYU Longone Health, New York, New York
• Duke University Medical Center, Durham, North Carolina

31 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07246863
• NCI Drug Dictionary: C179558

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 25, 2026. Public record; not medical advice.