Phase II Study of Cemiplimab and Fianlimab Given Before Surgery to Treat Stage IB to IIIB Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a fixed dose combination of cemiplimab and fianlimab given before surgery to treat patients with stage IB to IIIB non-small cell lung cancer NSCLC. This phase II trial aims to see how well these immunotherapy drugs, which help the immune system attack cancer and may stop tumor growth and spread, work in patients with specific PD-L1 expression levels. The study focuses on measuring the major pathologic response rate, which means how much the tumor is reduced after treatment, along with survival and other outcomes. Participants receive cemiplimab and fianlimab intravenously over 30 minutes on the first day of each 21-day treatment cycle. They may receive up to three cycles if there is no disease progression or unacceptable side effects. Before treatment, patients undergo MRI scans, and during the study, tissue and blood samples are collected along with CT and PETCT scans. After completing the study treatment, patients may have standard surgery to remove the cancer. Participants are followed closely with visits at 90 days after treatment, then every three months for two years, and every six months up to five years after surgery. Researchers will assess tumor response, survival rates, surgical outcomes, and side effects. The study also includes biomarker analyses from tissue and blood samples to better understand treatment effects and disease progression. This long-term follow-up helps monitor safety and disease status over time.

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