Active Not RecruitingPhase 2NCT05553834

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

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.

Checked against the public recordLast updated Apr 13, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 2
U.S. locations2
SponsorDuke University
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Duke University
Interventions being studied
Combination Product: Alirocumab and Cemiplimab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically documented recurrent and/or metastatic non-small cell lung cancer * Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment * If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required * Measurable disease by RECIST 1.1 * ECOG Performance Status 0 or 1 * Signed written informed consent * Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment * Meet all the laboratory criteria per protocol Exclusion Criteria: * Prior treatment with PCSK9 inhibitors * Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications. * Uncontrolled diabetes mellitus, defined as HbA1c \> 10 * Major surgery less than 4 weeks prior to study enrollment * Another malignant condition diagnosed within 3 years of study enrollment * Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication. * Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS) * Additional exclusion criterion as per listed in the protocol

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Moffitt Cancer CenterTampa, Florida
  • Duke UniversityDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 13, 2026. Always confirm current availability with the study team.

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