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
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Brain Metastases
Drug: icotinib
Radiation: Whole brain radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
    All cause adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516983

Locations
China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: You Lu West China Hospital
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01516983     History of Changes
Other Study ID Numbers: BD-IC-IV04
Study First Received: January 10, 2012
Last Updated: February 13, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Betta Pharmaceuticals Co.,Ltd.:
Safety
EGFR-TKI
NSCLC
Icotinib
WBRT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014