A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification

Summary

Primary Objective: To determine objective response rate (ORR). Secondary Objectives: To assess duration of response (DR), progression free survival (PFS) and overall survival (OS). To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplification. To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.

Timeline

Start

2015-11

Primary completion

2016-01

Completion

2016-01

Drugs

Indications