A Phase 2 interventional study of Alirocumab and Cemiplimab in Non-small Cell Lung Cancer (NSCLC), sponsored by Duke University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination of anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab
Combination Product: Alirocumab and Cemiplimab
Combination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab 350mg IV q3 weeks
Response rate associated with combination of alirocumab and cemiplimab
Ascertain the response rate associated with alirocumab and cemiplimab, with 95% confidence intervals. Response rate is defined as the proportion of treated subjects with a complete or partial response per RECIST 1.1 criteria. All patients who receive at least one dose of alirocumab and cemiplimab will be considered for the primary outcome analysis
Time frame: Day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks per RECIST 1.1
Safety and tolerability of the combination regimen
Toxicity analysis will be performed on a continual basis following CTC V 5.0 criteria
Time frame: Day 1 of treatment until 30 days post last dose
Progression Free Survival
Progression Free Survival will be assessed utilizing RECIST 1.1 criteria
Time frame: Day 1 of treatment until the date of first documented progression or date of death, whichever comes first, assessed up to 110 weeks
Overall survival
Patients will be followed till death or off study due to any other reason
Time frame: Day 1 of treatment until death or off study due to any other reason whichever comes first, assessed up to 110 weeks
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Duke University