Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
OxOnc Development LP
Age
18–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
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
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
You may not be if
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
