RecruitingPhase 2NCT06918132

Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)

Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8

Summary

This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving two immunotherapy drugs — cemiplimab and fianlimab — before surgery can shrink tumors and improve outcomes for patients with resectable (surgically removable) non-small cell lung cancer (NSCLC) at stages IB through IIIB. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage IB-IIIB NSCLC confirmed by tissue biopsy - Your tumor expresses PD-L1 (at least 1%) - A thoracic surgeon has confirmed that complete surgical removal is achievable - You have measurable disease and good performance status (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer is T4 stage for reasons other than large size (e.g., invasion of nearby structures) - You have already received chemotherapy or immunotherapy for this cancer - You have had prior lung cancer treatment with radiation - Your PD-L1 is less than 1% 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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