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Also known as Alirocumab
Alirocumab and Cemiplimab · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Alirocumab and Cemiplimab | EXPERIMENTAL | Combination of anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab |
| Name | Type | Description |
|---|---|---|
| Alirocumab and Cemiplimab | COMBINATION_PRODUCT | Combination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab 350mg IV q3 weeks |
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 prio...
Alirocumab is a drug being studied for use in sepsis, heterozygous familial hypercholesterolemia, non-small cell lung cancer (NSCLC), hypercholesterolemia, and homozygous familial hypercholesterolemia. It is currently in Phase 3 clinical development and is not yet approved for any of these indications.
Alirocumab is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy across several conditions, including hypercholesterolemia and sepsis.
Alirocumab is currently in Phase 3 clinical development. It has completed six trials and has one active trial ongoing. The drug is investigational and has not been approved by regulatory authorities for any use.
Alirocumab has been studied in several clinical trials, including NCT01266876, NCT01576484, NCT01604824, and NCT02326220. These trials have investigated the drug in patients with hypercholesterolemia and heterozygous familial hypercholesterolemia, with some studies completed and one ongoing.
Alirocumab and Cemiplimab are listed as alternative names for the same drug. However, the drug is primarily referred to as Alirocumab in clinical trials, and Cemiplimab may be an alternate designation used in some contexts.