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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516983
• Other study ID #: BD-IC-IV04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2012
• Last updated: February 13, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

Drug:
• icotinib
Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity. Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity. Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity. Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity.

Radiation:
• Whole brain radiotherapy
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	All cause adverse events (AEs) and serious adverse events (SAEs)	6-12 months	Yes
Secondary	Neurological progression-free survival	All cause neurological progress or mortality	3-6 month	No
Secondary	Progression-free survival	All cause progress or mortality	3-6 months	No
Secondary	Overall survival	All cause mortality	6-12 months	No
Secondary	Response rate		3-6 month	No
Secondary	Quality of life measured by FACT-L/LCS 4.0		1 year	No
Secondary	Neurocognitive effects	Evaluated according to Mini-Mental Status Examination	3-6 months	No