TOP 2301: Neoadjuvant Chemo for NSCLC - Trial NCT06385262
Access comprehensive clinical trial information for NCT06385262 through Pure Global AI's free database. This Phase 2 trial is sponsored by Duke University and is currently Not yet recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 126 participants.
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Study Focus
Sponsor & Location
Duke University
Timeline & Enrollment
Phase 2
Jul 01, 2024
Jun 30, 2028
Primary Outcome
Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab.
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06385262
Non-Device Trial