This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Crizotinib, 250 mg BID, will be administered orally at approximately the same time each day on a continuous daily dosing schedule
Objective Response Rate
Time frame: 33 months
Progression-Free Survival
Time frame: 33 months
Overall Survival
Time frame: 33 months
Disease Control Rate
Time frame: 33 months
Duration of Response
Time frame: 33 months
Time To Response
Time frame: 33 months
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