Status:
UNKNOWN
Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Collaborating Sponsors:
Nanchang University
Conditions:
Leptomeningeal Metastasis
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Leptomeningeal metastasis (LM) is a fatal complication of advanced non-small cell lung cancer (NSCLC) associated with poor prognosis and rapid deterioration of performance status. The incidence of LM ...
Detailed Description
This is a phase II pilot study to evaluate the efficacy and safety of osimertinib with bevacizumab for LM from EGFRm NSCLC patients. ALL patients were treated with Osimertinib 80mg oral daily and beva...
Eligibility Criteria
Inclusion
- Age in 18-80 years
- Pathologically proven NSCLC
- EGFR mutation , the EGFR status was identified from primary lung tumors using the amplification refractory mutation system (ARMS) or next-generation sequencing (NGS) analysis.
- LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
- No severe abnormal liver and kidney function;
- No other severe chronic diseases;
- Signed informed consent form
Exclusion
- Patients with the clinical manifestation of nervous system failure including severe encephalopathy, grade III-IV white matter lesions confirmed by imaging examination, moderate or severe coma, and glasgow coma score less than 9 points;
- Allergic to osimertinib or bevacizumab
- Any of the following: Pregnant women ;Nursing women ;Men or women of childbearing potential who are unwilling to employ adequate contraception
- History of myocardial infarction or other evidence of arterial thrombotic disease (angina), symptomatic congestive heart failure (New York Heart Association ≥ grade 2), unstable angina pectoris, or cardiac arrhythmia; Note: allowed only if patient has no evidence of active disease for at least 6 months prior to randomization;
- History of cerebral vascular accident (CVA) or transient ischemic attack (TIA)≤ 6 months prior to randomization
- History of bleeding diathesis or coagulopathy
- History of hemoptysis da≥ grade 2 (defined as bright red blood of at least 2.5 mL) ≤3 months prior to randomization
- Leukocytes below 2\*10\^9/L, neutrophils below 1\*10\^9/L; platelets below 50\*10\^9/L;
- Had major surgery within 60 days;
- History of arteriovenous thrombosis
- Gastrointestinal perforator in the past 6 months
- Inadequately controlled hypertension (systolic blood pressure of \> 150 mmHg or diastolic pressure \> 100 mmHg on anti-hypertensive medications); Note: history of hypertensive crisis or hypertensive encephalopathy not allowed
- Grade 4 proteinuria
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04425681
Start Date
October 1 2017
End Date
June 1 2021
Last Update
June 11 2020
Active Locations (1)
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1
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006