Status:

COMPLETED

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

Lead Sponsor:

Betta Pharmaceuticals Co., Ltd.

Conditions:

Non-small Cell Lung Cancer

Brain Metastases

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

PHASE2

Brief 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...

Detailed Description

The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT01516983

Start Date

December 1 2011

End Date

December 1 2013

Last Update

February 17 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

West China Hospital

Chengdu, Sichuan, China, 610041