NCT03916627

Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients

A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to better understand whether or not cemiplimab by itself and in combination with other treatments given prior to surgery will cause your tumor to respond in a beneficial way; whether the drug(s) are safe and what side effects they cause; and other details about how they function in the body. One of the treatments that will be combined cemiplimab is another experimental drug called fianlimab. In this form, cemiplimab and fianlimab will each individually be called "study drug" or "study drugs" when combined. Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved in your cancer. * Cemiplimab is a drug that blocks the programmed death receptor 1 (PD-1), a cell receptor on immune cells * Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)

Conditions

• Non-small Cell Lung Cancer
• Hepatocellular Carcinoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	cemiplimab	Administered intravenous (IV)
DRUG	Platinum Doublet	Administered intravenous (IV)
DRUG	fianlimab	Administered IV

Timeline

• Start date: 2019-07-23
• Primary completion: 2025-03-31
• Completion: 2030-05-14
• First posted: 2019-04-16
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study