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NCT Number: NCT01516983

Icotinib Combined With WBRT 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.

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Key information

Conditions

Non-small Cell Lung Cancer Brain Diseases Brain Metastases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Icotinib

Drug

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

whole brain radiotherapy

Radiation

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

Primary outcomes

  1. Safety and tolerability

    Time frame: 6-12 months

    All cause adverse events (AEs) and serious adverse events (SAEs)

Secondary outcomes

  1. Neurological progression-free survival

    Time frame: 3-6 month

    All cause neurological progress or mortality

  2. Progression-free survival

    Time frame: 3-6 months

    All cause progress or mortality

  3. Overall survival

    Time frame: 6-12 months

    All cause mortality

  4. Response rate

    Time frame: 3-6 month

  5. Quality of life measured by FACT-L/LCS 4.0

    Time frame: 1 year

  6. Neurocognitive effects

    Time frame: 3-6 months

    Evaluated according to Mini-Mental Status Examination

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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