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Clinical Trial Summary

Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is a challenge whether the further dose escalation of Icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators examine the therapeutic effect and side-effect of double dose of Icitinib in treating patients with brain metastases from NSCLC who have suffered from the failure of conventional dose treatment.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01688713
Study type Interventional
Source Zhejiang Cancer Hospital
Contact Yun Fan, MD
Phone 0086-571-88122192
Email fanyun@csco.org.cn
Status Recruiting
Phase Phase 2
Start date August 2012
Completion date September 2015

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