TOP 2301: Neoadjuvant Chemo for NSCLC
- Disease/Condition
- Non Small Cell Lung Cancer
- Drug/Device/Intervention
- Alirocumab
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- Duke University
- Phase
- Phase 2
- Start date
- Jul 01, 2024
- End date
- Jun 30, 2028
- Enrollment
- 126 participants
Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab.
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06385262
- Type
- Non-Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.