U.S., April 26 -- ClinicalTrials.gov registry received information related to the study (NCT06385262) titled 'TOP 2301: Neoadjuvant Chemo for NSCLC' on April 22.
Brief Summary: In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer 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 t...