TOP 2301: Neoadjuvant Chemo for NSCLC

This study was originally opened on 10/22/2024 as an open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) to receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery. As of 7/20/2026, the study was amended to a single arm receiving neoadjuvant chemotherapy, cemiplimab every 3 weeks for 3 cycles and alirocumab every 4 weeks prior to surgery. The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor c

Trial Details

NCT ID
NCT06385262
Phase
PHASE2
Sponsor
Duke University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Alirocumab
  • Cemiplimab
  • Chemotherapy
Locations (sample)
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Age ≥ 18 years.
  • Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Patient is eligible to enroll in the study based on clinical suspicion of…
  • Clinical stage IB, IIA/IIB, or III (N0-2) amenable to surgical resection.
  • Agrees to research blood collections for study.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Lung Cancer Trials on Trialify →