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

Running, not enrolling · Phase 2

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT05553834

Run by

Duke University

People needed

60

Starts

2023-05-16

Expected to finish

2026-11-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.