TOP 2301: Neoadjuvant Chemo for NSCLC

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06385262
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Alirocumab — DRUG
    300 mg subcutaneously every 4 weeks prior to surgery
  • Cemiplimab — DRUG
    350mg IV every 3 weeks prior to surgery
  • Chemotherapy — DRUG
    Treating provider's choice of FDA approved platinum doublet chemotherapy IV every 3 weeks prior to surgery

Study Details

This study was originally opened on 10/22/2024 as an open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) to receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery. As of 7/20/2026, the study was amended to a single arm receiving neoadjuvant chemotherapy, cemiplimab every 3 weeks for 3 cycles and alirocumab every 4 weeks prior to surgery. The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor.

Key Dates

First listed
Apr 26, 2024
Start date
Mar 17, 2025
Status verified
Aug 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2029

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Chemotherapy and cemiplimab (PD-1 inhibitor) every 3 weeks for 3 cycles with alirocumab (PCSK9 inhibitor) every 4 weeks prior to surgery.
  • Experimental: Arm B
    Chemotherapy and cemiplimab (PD-1 inhibitor) every 3 weeks for 3 cycles without alirocumab (PCSK9 inhibitor) prior to surgery. This ARM was closed as of 7/20/2026

Primary Outcome Measure

Evaluate the pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab with alirocumab. [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

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By research site
Duke University· Durham, NC

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