X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer.
2. Evidence of positive ALK.
3. Patients must have demonstrated progression during or after crizotinib treatment.
4. Age 18 years or older at the time of informed consent.
5. Eastern cooperative oncology group performance status (ECOG PS) of 0-2
6. Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
7. Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants.
8. Willingness and ability to comply with the trial and follow-up procedures.
9. Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

1. Prior use of ALK TKIs with the exception of crizotinib.
2. Patients currently receiving cancer system therapy.
3. Use of an investigational drug within 4 weeks prior to the first dose of study drug.
4. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
5. Patients with a known allergy or delayed hypersensitivity reaction to drugs.