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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer; Brain Metastases
• Interventions: Drug: icotinib; Radiation: Whole brain radiotherapy

• Registration Number: NCT01516983
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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 mutation.

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 improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-25
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib+WBRT	Whole brain radiotherapy	Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
Icotinib+WBRT	icotinib	Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	6-12 months	All cause adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
Response rate	3-6 month
Quality of life measured by FACT-L/LCS 4.0	1 year
Neurological progression-free survival	3-6 month	All cause neurological progress or mortality
Progression-free survival	3-6 months	All cause progress or mortality
Overall survival	6-12 months	All cause mortality
Neurocognitive effects	3-6 months	Evaluated according to Mini-Mental Status Examination

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China