Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
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
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 crizotinib.
You may not be if
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 radiation pneumonitis.
