RecruitingPhase 2NCT06449313

Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement

A Phase 2 Single-Arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement


Sponsor

Georgetown University

Enrollment

21 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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 contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving chemotherapy plus immunotherapy before surgery can shrink locally advanced non-small cell lung cancer with certain lymph node involvement (N3 disease), making the tumor removable and improving long-term outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage IIIB or IIIC non-small cell lung cancer with confirmed N3 lymph node spread - Your surgeon believes the primary tumor could potentially be removed after treatment - You are in good enough overall health to tolerate surgery **You may NOT be eligible if...** - Your cancer has spread beyond the chest (distant metastases) - You have major health conditions that make surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab-Rwlc

350 mg every 3 weeks, intravenously, on day 1 of a 21 day cycle for 4 cycles, then every 3 weeks after surgery for 1 year.


Locations(3)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, United States

Washington University School of Medicine-Sitemen Cancer Center

St Louis, Missouri, United States

UVA Comprehensive Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06449313


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