Status:
UNKNOWN
Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Non-Small Cell Lung Cancer
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03754530
Start Date
December 1 2018
End Date
December 1 2021
Last Update
November 27 2018
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