In the trial, the company has involved patients previously treated with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) who will receive ARQ 197 plus erlotinib or placebo plus erlotinib.
Daiichi Sankyo and ArQule informed that the primary objective of the trial is to investigate the overall survival (OS) in the intent-to-treat (ITT) population.
Whereas, the seconday endpoint include OS in the subpopulation of patients with epidermal growth factor receptor (EGFR) wild type, progression-free survival (PFS) in the ITT population, and further assessment of the safety of ARQ 197 in combination with erlotinib.
ArQule CEO Paolo Pucci said the start of this Phase 3 trial marks a key milestone in the development of ARQ 197 and our partnership with Daiichi Sankyo.
"Lung cancer is a devastating disease and our hope is that ARQ 197 will prove to be an effective treatment option that will help patients diagnosed with this disease."