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

In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery. Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1). 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

Start date
Mar 17, 2025
Status verified
Mar 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
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

Primary Outcome Measure

Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab. [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Duke University· Durham, NC

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