drugset / Trial / NCT05553834

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

NCT05553834

Phase 2 Active not recruiting 60 enrolled Duke University Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

Summary

PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can generate anti-tumor activity and clinical responses in patients with metastatic lung cancer who have progressed on first line immune checkpoint blockade therapy.

Timeline

Start
2023-05-16
Primary completion
2025-09-16
Completion
2026-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody 150 mg Subcutaneous
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous