Status:
UNKNOWN
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Non Small Cell Lung Cancer
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint ...
Detailed Description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show ...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
- Positive EGFR mutation（Ex19del or 21L858R）
- Primary diagnosis of brain metastases
- Have one or more measurable encephalic lesions according to RECIST
- Extracranial transfer organ≤3
- ECGO:0-2
- Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
- Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and -Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
- Female subjects should not be pregnant.
- All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Written informed consent provided.
Exclusion
- Previous usage of EGFR-TKI : gefitinib, erlotinib, icotinib，or any other TKI
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
- Participate in the other anti-tumor clinical trials in 4 weeks. have quit from the trail before.
- Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Key Trial Info
Start Date :
July 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT04058704
Start Date
July 20 2018
End Date
December 31 2022
Last Update
August 15 2019
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China