SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung Cancer Patients

• Status: Recruiting
• Trial end date: 2024-03-01

Summary

Primary Objectives:

Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff 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 NSCLC expressing CEACAM5 ≥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 ≥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 with docetaxel

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel; Maytansine