Abbreviations
CRIZ
chemo
172
171
Phase:
3
Open label
NSCLC
ALK poz., Nonsquamous
meta
L1
- 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 with no ongoing requirement for corticosteroids - 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. - 18 years of age or older with the exception of India which has an upper age limit of 65 years old
- 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 CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices. - Known HIV infection - Known interstitial lung disease or interstitial fibrosis - Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditi