Back to resultsIcotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
Primary Purpose
Non-small Cell Lung Cancer, Brain Metastases
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
icotinib
Whole brain radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Safety, EGFR-TKI, NSCLC, Icotinib, WBRT
Eligibility 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.
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib+WBRT
Arm Description
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
Outcomes
Primary Outcome Measures
Safety and tolerability
All cause adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
Neurological progression-free survival
All cause neurological progress or mortality
Progression-free survival
All cause progress or mortality
Overall survival
All cause mortality
Response rate
Quality of life measured by FACT-L/LCS 4.0
Neurocognitive effects
Evaluated according to Mini-Mental Status Examination
Full Information
NCT ID
NCT01516983
First Posted
January 10, 2012
Last Updated
February 13, 2014
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01516983
Brief Title
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Brain Metastases
Keywords
Safety, EGFR-TKI, NSCLC, Icotinib, WBRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Icotinib+WBRT
Arm Type
Experimental
Arm Description
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
icotinib
Other Intervention Name(s)
BPI-2009, Conmana
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Whole brain radiotherapy
Other Intervention Name(s)
RT, XRT, Radiotherapy, WBRT
Intervention Description
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
All cause adverse events (AEs) and serious adverse events (SAEs)
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Neurological progression-free survival
Description
All cause neurological progress or mortality
Time Frame
3-6 month
Title
Progression-free survival
Description
All cause progress or mortality
Time Frame
3-6 months
Title
Overall survival
Description
All cause mortality
Time Frame
6-12 months
Title
Response rate
Time Frame
3-6 month
Title
Quality of life measured by FACT-L/LCS 4.0
Time Frame
1 year
Title
Neurocognitive effects
Description
Evaluated according to Mini-Mental Status Examination
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Lu
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Learn more about this trial
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
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