- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or
- Positive for translocation or inversion events involving the ROS1 gene as determined
by protocol defined test.
- ECOG performance status 0 to 2.
- Adequate organ function
- Patients with brain metastases are eligible if neurologically stable for at least 2
weeks and have no ongoing requirement for corticosteroids.
- Male patients able to father children and female patients of childbearing potential
and at risk for pregnancy must agree to use 2 highly effective methods of
contraception throughout the study and for at least 90 days after the last dose of
- Currently receiving crizotinib or any investigational products.
- Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
- Carcinomatous meningitis or leptomeningeal disease.
- Spinal cord compression unless treated with the patient attaining good pain control
and stable or recovered neurologic function.
- Ongoing uncontrolled congestive heart failure (CHF) and any of the following within
the 3 months prior to starting study treatment: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including
transient ischemic attack.
- Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any
grade, or QTc more than 480 msec.
- History of extensive disseminated/bilateral or known presence of Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior
- Pregnant female patients; breastfeeding female patients.
- Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4
inducers and CYP3A4 substrates with narrow therapeutic indices