The study is a randomized, double-blinded, controlled study of tivantinib plus erlotinib, versus placebo plus erlotinib in patients who have received prior treatment for advanced, non-squamous NSCLC.
The primary objective of the study is to investigate overall survival (OS) in the intent-to-treat (ITT) population.
The secondary endpoints include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, the time patients in the ITT population live without their disease getting worse (progression-free survival or PFS), and further assessment of the safety of tivantinib in combination with erlotinib.
Daiichi Sankyo Pharma Development chief science officer and president Glenn Gormley said they hope that this late-stage study will confirm the results observed with tivantinib in phase II.