Overview

Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Betta Pharmaceuticals Co.,Ltd.
Criteria
Inclusion Criteria:

- Histological or cytological confirmation of non-small cell lung cancer (NSCLC).

- Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of
intracranial metastases, or the longest diameter of the intracranial lesion is more
than 3cm.

- Positive EGFR mutation.

Exclusion Criteria:

- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin,
erbitux.

- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.