Primary Objectives:
* Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\])
* Study success is defined either on PFS or OS
* The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
* The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.
Secondary Objectives:
* To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
* To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
* To evaluate the safety of tusamitamab ravtansine compared to docetaxel
* To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic nonsquamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors
To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.