Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Inclusion Criteria:

* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
* treatment-naïve or have received no more than 3 systemic treatment regimen(s)
* Positive for translocation or inversion events involving the ROS1 gene
* Negative for translocation or inversion events involving the ALK gene
* Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
* Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
* At least 1 measurable tumor lesion as per RECIST v1.1
* Female or male, 18 years of age or older
* ECOG performance status 0 to 1
* Adequate organ function
* Signed and dated informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
* Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Exclusion Criteria:

* Current treatment on another therapeutic clinical trial
* Prior therapy specifically directed against ALK or ROS1 fusion genes
* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
* known interstitial fibrosis or interstitial lung disease
* myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
* Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade \>/=2, uncontrolled atrial fibrillation of any grade, or QTc \>470 msec
* Pregnant or breast feeding
* Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
* Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
* Evidence of active malignancy within last 3 years