TOP 2301: Neoadjuvant Chemo for NSCLC

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Recruitment resumed after suspension
    • Eligibility criteria expanded, about 46 words
    • Site details revised
  2. Enrollment target: 126 to 63
    • Primary endpoints: 1 to 2
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoints: 5 to 6
    v11
  3. Trial status: Recruiting to Suspended Sponsor's reason: Protocol is currently undergoing study design revisions and will re-open after amendment is IRB approved
    • Primary completion date: Oct 30, 2027 to Oct 30, 2028
    • Site details revised
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Start date changed from estimate of Mar 3, 2025 to Mar 17, 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Aug 30, 2026 to Oct 30, 2027
    • Start date: Dec 15, 2024 to Mar 3, 2025
    • Study completion date: Aug 30, 2028 to Oct 30, 2029
    • Site contact updated
    v7
  2. Start date: Nov 1, 2024 to Dec 15, 2024v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  4. Start date: Sep 1, 2024 to Nov 1, 2024
    • Primary completion date: Jun 30, 2026 to Aug 30, 2026
    • Study completion date: Jun 30, 2028 to Aug 30, 2028
    v4
  5. Start date: Jul 1, 2024 to Sep 1, 2024v3
  6. Eligibility criteria expanded, about 30 words
    • Secondary endpoints revised (5)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor.
Trial Details
NCT Number NCT06385262
Lead Sponsor Duke University
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov