TOP 2301: Neoadjuvant Chemo for NSCLC

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06385262
Study type	Interventional
Source	Duke University
Contact	Neal Ready, MD, PhD
Phone	+1 919 681 6932
Email	neal.ready@duke.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	July 1, 2024
Completion date	June 30, 2028

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