Socinski et al recently described the activity of sunitnib malate (SU11248) an oral, multitargeted tyrosine kinase inhibitor targeting VEGFR, PDGFR, KIT, FLT3 and RET on tumor cells, tumor neovasculature and pericytes. In an open-label, two-stage, multicenter phase II trial evaluating the single-agent activity of sunitinib in refractory NSCLC, patients with confirmed diagnosis of NSCLC, ECOG PS 0-1, no recent gross hemoptysis, no brain metastases, patients (pts) previously treated with 1-2 chemotherapy regimens, and adequate end-organ function, pts received sunitinib at 50 mg/day po for 4 weeks (wks) followed by 2 wks off treatment (6 wks considered a cycle). A total of 64 pts were enrolled and 63 pts treated. Six confirmed partial responses have been observed among 63 treated patients. Stable disease has been observed in an additional 12 pts (19.0% of all treated patients). Based on this study, Sunitinib appeared to have single-agent activity in previously treated pts with recurrent and advanced NSCLC, with the level of activity similar to currently approved agents. Sunitinib was well tolerated in this population. The trial was extended to explore a continuous dosing strategy of sunitinib at 37.5 mg/day po.