An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy
Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased
type of cancer in China with over 5 times incidence rate increase during the past 30 years.
Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been
widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib
is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib
appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and
larger of therapeutic window in phase I-III trials. In this study, an open , single-center,
single arm phase IV trial was designed to evaluate the safety and efficacy of dose
escalation of icotinib in the treatment of advanced NSCLC patients after failure with
routine dose. 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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Li Xi qing, M.D.
307 Hospital of People's Liberation Army（PLA）
China: Food and Drug Administration