NCT06385262

TOP 2301: Neoadjuvant Chemo for NSCLC

Safety, Efficacy, and Tumor Immune Microenvironment Changes With Neoadjuvant Chemotherapy and Cemiplimab With or Without Alirocumab in Stage 1B-3A Non-Small Cell Lung Cancer: TOP 2301

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alirocumab	300 mg subcutaneously every 4 weeks prior to surgery
DRUG	Cemiplimab	350mg IV every 3 weeks prior to surgery
DRUG	Chemotherapy	Treating provider's choice of FDA approved platinum doublet chemotherapy IV every 3 weeks prior to surgery

Timeline

• Start date: 2025-03-17
• Primary completion: 2028-10-30
• Completion: 2029-10-30
• First posted: 2024-04-26
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study