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

February 13, 2014 updated by: Betta Pharmaceuticals Co., Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West china hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Icotinib+WBRT
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
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.

Other Names:
  • BPI-2009, Conmana
Radiation: Whole brain radiotherapy
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
Other Names:
  • Radiotherapy
  • RT
  • XRT
  • WBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 6-12 months
All cause adverse events (AEs) and serious adverse events (SAEs)
6-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-IV04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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