- 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
- 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