Phase 2 Study Comparing Cemiplimab Plus Chemotherapy With or Without Additional Cancer Treatment for Adults With Operable Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating treatments for adults with early-stage stage II-IIIB non-small cell lung cancer who are scheduled for surgery. The study compares an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug, REGN7075, against cemiplimab plus chemotherapy without the additional drug. The study also investigates side effects, effects on surgery type, drug levels in blood, and the bodys antibody response to the drugs. Participants are randomly assigned to one of two study groups one group receives cemiplimab plus chemotherapy, and the other group receives cemiplimab plus chemotherapy plus REGN7075. All drugs are given by intravenous infusion. The study focuses on the period leading up to surgery and includes up to 12 weeks for assessing major pathologic response and other tumor-related outcomes. During the study, participants will undergo medical evaluations including tumor measurements using pathology review, blood tests to monitor drug levels and antibodies, and assessments of side effects. Researchers will track event-free and overall survival outcomes for up to 5 years and monitor adverse events for up to 76 weeks. The total study duration may extend to several years for long-term monitoring of treatment effects and safety.

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)