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SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients — CARMEN-LC03  

Non-small Cell Lung Cancer Metastatic Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

The expected duration of study intervention for participants who benefit from study intervention may vary, based on progression date; but median expected duration of study per participant is estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the EOT and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04154956
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 6, 2020
Completion date August 26, 2026
View Details
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