Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

Inclusion Criteria: * Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally. * Eastern cooperative oncology group (ECOG) performance status ≤ 2. * Measurable disease as per RECIST v1.1 * Availability of tumor sample: For ALK inhibitor naïve patients: o A representative tumor sample must be submitted. An archival tumor specimen is acceptable For patients after progression on an ALK inhibitor: o A new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent ALK inhibitor is available for submission For all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. In the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor. Exclusion Criteria: * For Phase I part: o Patients who have not previously received at least one line of therapy for ALK-positive NSCLC * For Phase II part: * Group A: prior therapy with any ALK inhibitor is not permitted. * Group B: progression following any ALK inhibitor(s) other than ceritinib is required and the last dose of the ALK inhibitor must be no more than 60 days prior to the first dose of study drug. Prior ceritinib is not permitted. * Grou…