PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung
Active, not recruiting · Phase 2 · NCT05553834
Conditions: Non-small Cell Lung Cancer (NSCLC)
At a glance
- Research payments reported, 2025
- $433,327
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 60
About the trial
- Sponsor
- Duke University (with Regeneron Pharmaceuticals)
- Tested
- Alirocumab and Cemiplimab (combination_product)
- Dates
- Started 2023-05-16; completion 2026-11-01
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-11-04. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $433,327 in research payments for this study in 2025 (17 payments).
Products named: Libtayo
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Duke University $433,327
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.