a study of crizotinib versus chemotherapy in previously untreated alk positive east asian non-small cell lung cancer patients

Conditions: NSCLC (Non-small Cell Lung Cancer)

Summary: this is a phase iii, randomized, open-label, efficacy and safety study of crizotinib single agent versus chemotherapy regimens (pemetrexed/cisplatin or pemetrexed/carboplatin) in first-line alk (anaplastic lymphoma kinase) positive east asian non-small cell lung cancer patients. the objective of the study is to demonstrate that crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging progression free survival (pfs) in east asian patients with advanced non-squamous nsclc whose tumors harbor a translocation or inversion event involving the alk (anaplastic lymphoma kinase) gene locus.


Eligibility criteria:
inclusion criteria: * 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 are not taking any medications contraindicated in exclusion criteria * 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.

Keywords: crizotinib alk positive alk anaplastic lymphoma kinase nsclc non-small cell lung cancer frontline 1l previously untreated east asian non-squamous