A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy
Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence
rate increase during the past 30 years . It is the leading cause of death of cancer in man
and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal
growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs
developed for the treatment of these patients in recent years, especially for NSCLC patients
in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese
scientists and clinician. It appears to be at least as good as gefitinib in terms of
efficacy and better in terms of safety in phase I/II trials. In this study, a randomized,
double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate
the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after
failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with
OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as
the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene
mutational analysis as well as a population PK study have also been proposed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Yan Sun, M.D.
Cancer Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration