The objective of this trial is to evaluate the anti-tumor activity of IPI-504 in patients with non-small cell lung cancer (NSCLC). Initially, the phase II portion of the study will enroll a total of 20 patients in two equal groups, one group with known epidermal growth factor receptor (EGFR) mutations and one group with wild-type EGFR. Evidence of anti-tumor activity will be evaluated using RECIST criteria (response evaluation criteria in solid tumors).
If sufficient evidence of clinical benefit is observed in either cohort, 19 additional patients will be enrolled in that cohort. IPI-504 is being administered intravenously at 400mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment.