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RECRUITING
NCT06918132
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-04-29

Completion Date

2027-04-29

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo tissue and blood sample collection

BIOLOGICAL

Cemiplimab

Given IV

BIOLOGICAL

Fianlimab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Surgical Procedure

Undergo SOC surgery

PROCEDURE

Computed Tomography

Undergo CT and PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States