OncRef

Clinical Trial: NCT05553834

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Duke University
Information Provided By:Duke University
Last Update Posted:2026-04-13

Study Overview

Brief 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.

Official Title

A Phase II Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung Cancer: TOP2201

Conditions

Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment

  • Combination Product: Alirocumab and Cemiplimab

Other Study ID Numbers

  • PRO00111111

Start Date (Actual)

2023-05-16

Primary Completion Date (Actual)

2025-09-16

Study Completion Date (Estimated)

2026-11-01

Enrollment (Estimated)

60

Study Type

Interventional

Phase

Phase 2