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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01516983
First received: January 10, 2012
Last updated: February 13, 2014
Last verified: February 2014

January 10, 2012
February 13, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
All cause adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerality [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
All cause adverse events (AEs) and serious adverse events (SAEs)
Complete list of historical versions of study NCT01516983 on ClinicalTrials.gov Archive Site
  • Neurological progression-free survival [ Time Frame: 3-6 month ] [ Designated as safety issue: No ]
    All cause neurological progress or mortality
  • Progression-free survival [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    All cause progress or mortality
  • Overall survival [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    All cause mortality
  • Response rate [ Time Frame: 3-6 month ] [ Designated as safety issue: No ]
  • Quality of life measured by FACT-L/LCS 4.0 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Neurocognitive effects [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Evaluated according to Mini-Mental Status Examination
Same as current
Not Provided
Not Provided
 
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer
  • Brain Metastases
  • 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 Name: 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:
    • RT
    • XRT
    • Radiotherapy
    • WBRT
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.
Interventions:
  • Drug: icotinib
  • Radiation: Whole brain radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01516983
BD-IC-IV04
Yes
Betta Pharmaceuticals Co.,Ltd.
Betta Pharmaceuticals Co.,Ltd.
Not Provided
Principal Investigator: You Lu West China Hospital
Betta Pharmaceuticals Co.,Ltd.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP