IPI-504 in NSCLC Patients With ALK Translocations

Inclusion Criteria: * Patients must have pathologically confirmed diagnosis of Stage IIIb (with malignant pleural or pericardial effusion), Stage IV, or recurrent NSCLC. * Patients must have demonstrated ALK mutation * There is no requirement for a minimum or maximum number of prior therapies, however, patients must have refused, be intolerant to or already received at least on standard systemic therapy for lung cancer * Measureable disease by RECIST criteria. If a patient has received radiation therapy then measurable disease must be outside the radiation field. * 18 years of age or older * Life expectancy of at least 3 months * ECOG performance status of 0-2 * Baseline studies for determining eligibility, except for ALK mutation status, must be completed within 30 days of first study dose. * CT scan must be completed within 28 days prior to first study dose * Women of child-bearing potential (WBCP) defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months must have a negative serum or urine pregnancy test within 2 weeks of first study dose * All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study Exclusion Criteria: * Treatment for NSCLC with any approved or investigational product within 2 weeks of Cycle 1, Dose 1 for any small molecule therapy; within 4 weeks of Cycle 1, Dose 1 for any biologic or any conventiona…