RecruitingPhase 2NCT06623656

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer

Sponsor

Weill Medical College of Cornell University

Enrollment

112 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1. Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR 2. Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3. Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of pre-surgery treatment for people with resectable non-small cell lung cancer (NSCLC): radioimmunotherapy (radiation combined with immunotherapy) versus chemoimmunotherapy (chemotherapy combined with immunotherapy). Researchers want to see which approach better shrinks tumors before surgery and improves long-term survival. **You may be eligible if...** - You are over 18 with stage IB, II, or III (N2) NSCLC that can be removed with surgery - Your cancer does not have EGFR mutations or ALK fusions - You have not received any prior lung cancer treatment - Your physical health is good (ECOG 0 or 1) - You have adequate organ and bone marrow function **You may NOT be eligible if...** - You have EGFR mutations or ALK fusions - You have had prior treatment for lung cancer - Your cancer is not operable - You have poor organ function 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

Intravenously

DRUGPlatinum based chemotherapy

Intravenously

RADIATIONStereotactic body radiation therapy

8 Gy times 3 treatment days (Days 1-3)

Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT06623656

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