Phase I/Ii Multicenter, Randomized, Open-Label Trial Of The C-Met Inhibitor Msc2156119j And Gefitinib Versus Chemotherapy As Second-Line Treatment In Patients With Met-Positive (Met Plus ), Locally Advanced, Or Metastatic Non-Small Cell Lung Cancer (Nsclc) With Epidermal Growth Factor Mutation (Egfrm Plus ) And Progression On Gefitinib

TPS8121 Background: Resistance to EGFR tyrosine kinase inhibitors (eg, gefitinib) in EGFRm+ NSCLC patients (pts) is mainly caused by a secondary mutation in the EGFR (ie, T790M) or by activation of the c-Met/HGF signaling pathway (eg, protein overexpression and/or amplification). MSC2156119J, a highly selective small-molecule c-Met inhibitor, displayed promising antitumor activity in pts with advanced solid tumors in a Phase I trial (Falchook et al. J Clin Oncol 2013:31(Suppl):2506). This Phase Ib/II, multicenter, open-label trial investigates the antitumor activity of MSC2156119J + gefitinib in pts with MET+ advanced EGFRm+ NSCLC (NCT01982955). Methods: Primary objectives are determination of the recommended phase II dose (RP2D) for the combination (Phase Ib), and progression-free survival (PFS) per investigator read (Phase II). Secondary objectives include safety, pharmacokinetics, and antitumor activity of MSC2156119J (PFS per independent read, overall survival, objective response, and disease control)...