Rationale and study design of ARCHER: a randomized, double-blind, Phase III study of dacomitinib versus erlotinib for advanced non-small-cell lung cancer
作者： Michael Boyer , Pasi Antero Jänne , Tony Mok , Kenneth O’Byrne , Luis Paz-Ares
DOI: 10.4155/CLI.12.137
关键词:
摘要: Background: Dacomitinib (PF-00299804) is an irreversible pan-HER tyrosine kinase inhibitor. We describe the rationale and design of a Phase III, randomized, double-blind study dacomitinib versus erlotinib in patients with advanced non-small-cell lung cancer (NSCLC) following one or two prior lines therapy setting. Method: The primary end point progression-free survival per independent radiologic review co-primary patient populations: all NSCLC (∼800) confirmed KRAS wild-type (at least 400). powered to detect ≥33 45% improvement NSCLC, respectively. sample size will allow assessment difference overall populations adequate power (i.e., ≥80%).
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