Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer
Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
1. There is as yet no optimal treatment regimen for patients with epidermal growth factor
receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .
2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang
BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the
similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed
icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,
anti-tumor activities were observed in patients with advanced NSCLC.
3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in
combination with Docetaxel as second-line treatment for NSCLC patients with wild type
EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall
survival(OS) and health related quality of life(HRQoL) will be monitored.