- Histologically or cytologically proven diagnosis of locally advanced not suitable for
local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung.
- Positive for translocation or inversion events involving the ALK gene locus.
- No prior systemic treatment for locally advanced or metastatic disease. Patients with
brain metastases only if treated and neurologically stable for at least 2 weeks and
- Evidence of a personally signed and dated informed consent document and willingness
and ability to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures including completion of patient reported outcome [PRO]
measures.
Exclusion Criteria:
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
congestive heart failure, or cerebrovascular accident including transient ischemic
attack. Appropriate treatment with anticoagulants is permitted.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation
of any grade, or QTc interval >470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use
of drugs that are CYP3A substrates with narrow therapeutic indices.
- Known HIV infection
- 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.
- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal
disease on hemodialysis, or laboratory abnormalities that would impart, in the
judgment of the investigator and/or sponsor, excess risk associated with study
participation or study drug administration, and which would, therefore, make the
patient inappropriate for entry into this study.