Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Conditions
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Non-Small Cell Lung Cancer, Brain Metastases

Intervention / Treatment
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* Drug: Icotinib
* Radiation: WBRT or SRS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD | Drug: Icotinib<br>* orally three times per day<br>* Other names: WBRT or SRS;|
| Experimental: Icotinib plus radiation therapy<br>Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses. | Drug: Icotinib<br>* orally three times per day<br>* Other names: WBRT or SRS;Radiation: WBRT or SRS<br>* >3 with WBRT;<=3 with SRS<br>* Other names: Icotinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of intracranial lesions | Number of participants with progress of intracranial lesions | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Number of participants with progress of any places in body | 8 months | 
| Objective response rate of intracranial lesions | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC brain metastases