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Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features

Study acronym: NEO-SURG
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Aug 2026 to Nov 2026 Eligibility criteria expanded, about 53 words · Secondary endpoints: details revised at 1 of 5 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Site contacts updated at 1 of 3 sites Study title shortened, about 1 wordv10 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 84 words Site contacts updated at 1 of 3 sites · Study title expanded, about 5 wordsv9 Show 2 more changesShow less
    • Site contacts updated at 1 of 3 sites
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Apr 2026 to Aug 2026v8
  5. Start date: Jan 2026 to Apr 2026v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Dec 2025 to Jan 2026 Site details revised at 1 of 3 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 3 sites
  2. Study sites: 1 to 3 Start date: Nov 2025 to Dec 2025v5 Show 1 more changeShow less
    • Start date: Nov 2025 to Dec 2025
  3. Start date: Aug 2025 to Nov 2025v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2024 to Aug 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Sep 2024 to Aug 2025
    • Site details revised
  5. Eligibility criteria expanded, about 29 words Study title expanded, about 5 wordsv2 Show 1 more changeShow less
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with select N3 lymph node involvement or other high-risk subsets in which there is no consensus on resectability. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.
Trial Details
NCT Number NCT06449313
Lead Sponsor Georgetown University
Collaborators: Regeneron Pharmaceuticals
Conditions Non-small Cell Lung Cancer Stage III
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov