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Novartis Pharmaceuticals trial entitled: A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)
The purpose of this study is to learn whether the drug INC280 helps to control lung cancer, and whether it is safe when given to patients suffering from Non-small Cell Lung Cancer (NSCLC) who have received one or two prior therapies for their advanced cancer.
Primary Objective: The primary objective is to demonstrate the antitumor activity of INC280, as measured by overall response rate (ORR) to INC280 by Blinded Independent Review Committee (BIRC) assessment, by cohort. Secondary Objectives: Objective 1: To evaluate ORR and DOR by investigator assessment, by cohort. Objective 2: To evaluate time to response (TTR), disease control rate (DCR) and progression-free survival (PFS) by investigator and by BIRC assessment, by cohort. Objective 3: To evaluate overall survival (OS), by cohort. Objective 4: To evaluate INC280 safety profile as monotherapy in NSCLC patients who have received one or two prior lines of systemic therapy in advanced/metastatic setting. Objective 5: To characterize the pharmacokinetics of INC280.