Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 29, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06918132). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Lung Non-Small Cell Carcinoma, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8. Interventions: PROCEDURE: Biospecimen Collection; BIOLOGICAL: Cemiplimab; BIOLOGICAL: Fianlimab; PROCEDURE: Magnetic Resonance Imaging; PROCEDURE: Surgical Procedure; PROCEDURE: Computed Tomography; PROCEDURE: Positron Emission Tomography. Primary outcome measures: Major pathologic response (MPR) rate (Group A) , Up to 2 years; MPR rate (Group B) , Up to 2 years. Brief 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.