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TOP 2301: Neoadjuvant Chemo for NSCLC

NCT06385262 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-03-06

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Neal Ready, MD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2028-10-30
Completion
2029-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385262 on ClinicalTrials.gov