Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Inclusion Criteria:

• Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
• Histological or cytological confirmation of EGRF positive sensitive mutation
• Diagnosis of brain metastases on a Gadolinium-enhanced MRI

Exclusion Criteria:

• Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
• Previous usage of radiation with brain
• CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.