Brain Metastases, Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC brain metastases
Brief summary
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions
Detailed description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.
Interventions
DRUGIcotinib
orally three times per day
RADIATIONWBRT or SRS
\>3 with WBRT;\<=3 with SRS
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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) with brain metastases * Histological or cytological confirmation of EGRF positive sensitive mutation * Diagnosis of brain metastases on a Gadolinium-enhanced MRI
Exclusion criteria
* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux * Previous usage of radiation with brain * CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival of intracranial lesions | 10 months | Number of participants with progress of intracranial lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 8 months | Number of participants with progress of any places in body |
| Objective response rate of intracranial lesions | 8 weeks | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response |
Contacts
Primary ContactLi jiancheng
Backup ContactLi jiancheng
Outcome results
None listed