Non-small Cell Lung Cancer, Brain Metastases
Conditions
Keywords
Safety, EGFR-TKI, NSCLC, Icotinib, WBRT
Brief summary
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.
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.
Interventions
DRUGicotinib
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.
RADIATIONWhole brain radiotherapy
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 6-12 months | All cause adverse events (AEs) and serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3-6 months | All cause progress or mortality |
| Overall survival | 6-12 months | All cause mortality |
| Neurological progression-free survival | 3-6 month | All cause neurological progress or mortality |
| Quality of life measured by FACT-L/LCS 4.0 | 1 year | — |
| Neurocognitive effects | 3-6 months | Evaluated according to Mini-Mental Status Examination |
| Response rate | 3-6 month | — |
Countries
China
Outcome results
None listed