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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
West China Hospital
Chengdu, Sichuan, China
Safety and tolerability
All cause adverse events (AEs) and serious adverse events (SAEs)
Time frame: 6-12 months
Neurological progression-free survival
All cause neurological progress or mortality
Time frame: 3-6 month
Progression-free survival
All cause progress or mortality
Time frame: 3-6 months
Overall survival
All cause mortality
Time frame: 6-12 months
Response rate
Time frame: 3-6 month
Quality of life measured by FACT-L/LCS 4.0
Time frame: 1 year
Neurocognitive effects
Evaluated according to Mini-Mental Status Examination
Time frame: 3-6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.