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Alirocumab and Cemiplimab

Phase 2

Non-small Cell Lung Cancer (NSCLC) | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05553834PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell LungPHASE2 ACTIVE NOT_RECRUITING 60 — — May 16, 2023Nov 1, 2026Apr 13, 20262 United States
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Study Endpoints
Primary Endpoints
Response rate associated with combination of alirocumab and cemiplimab
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

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

Secondary Endpoints
Safety and tolerability of the combination regimen
Day 1 of treatment until 30 days post last dose
Progression Free Survival
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
Day 1 of treatment until death or off study due to any other reason whichever comes first, assessed up to 110 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Alirocumab and CemiplimabEXPERIMENTALCombination of anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab
Interventions
NameTypeDescription
Alirocumab and CemiplimabCOMBINATION_PRODUCTCombination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab 350mg IV q3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05553834studyFirstPostDate: changed