COVID-19 (Coronavirus) Update: Vaccine Updates | COVID-19 Information | Visitor Guidelines

Randomized, open label Phase 3 study of SAR408701 versus Docetaxel in previously treated metastatic non-squamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors

Protocol No
SANOFI-EFC15858
Principal Investigator
Jonathan Thompson
Phase
III
Summary
The purpose of this project is to find out if the new drug SAR408701 is better than Docetaxel, a drug already approved by the FDA for the treatment NSCLC patients with CEACAM 5 Positive tumor. SAR408701 consists of a drug component called DM4 that is very potent to kill tumor cells. This drug is linked to an antibody that recognizes a protein called CEACAM5 that is expressed at the surface of some types of cancer including lung cancer. The antibody component of SAR408701 binds to the CEACAM5 antigen expressed at the surface of the tumor cell. Then SAR408701 enters the tumor cells and the drug DM4 kills the cell. In summary, SAR408701 is a system to deliver a very potent anticancer drug specifically to the tumor cells that express the CEACAM5 protein. SAR408701 is investigational, meaning it has not been approved by the FDA for the treatment of lung cancer.
Description
Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic Non-Squamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors (CARMEN-LC03)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
Sub Category