An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

Inclusion Criteria: * Subjects with histologically or cytologically confirmed, unresectable NSCLC that carries a ROS1 rearrangement, as per FISH assay (Abbott Molecular Inc.) * ECOG performance status of 0 to 2 * Male or female; ≥ 20 years of age * Subjects must have received at least 1 platinum doublet to treat their locally advanced or metastatic NSCLC * Subjects whose disease has progressed within 6 months Subjects with measurable lesion (using RECIST 1.1 criteria) * Subjects must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2 * Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since * Provision of written informed consent prior to any study specific procedures Exclusion Criteria: * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy. * Any major operation or irradiation within 4 weeks of baseline disease assessment * Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug * Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ or treated thyroid cancer. * Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension) * Pregnant or lactating female * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study