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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Duke University
Study ID
NCT05553834
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab and Cemiplimab — COMBINATION_PRODUCT
    Combination of PCSK9 inhibitor Alirocumab 150mg SC q2weeks and PD-I inhibitor Cemiplimab 350mg IV q3 weeks

Study Details

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 Dates

Start date
May 16, 2023
Status verified
Apr 2026
Primary completion
Sep 16, 2025
Completion
Nov 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab and Cemiplimab
    Combination of anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab

Primary Outcome Measure

Response rate associated with combination of alirocumab and cemiplimab [ 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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Duke UniversityDurhamNorth Carolina27705-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLDuke University· Durham, NC

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