NCT02191059

Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer

Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib
DRUG	Docetaxel

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2016-07-01
• First posted: 2014-07-15
• Last updated: 2014-07-31

Locations

1 site across 1 country: China