To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.
Phase 2
- Conditions
- on-Small-Cell Lung Cancer
- Registration Number
- JPRN-UMIN000012515
- Lead Sponsor
- Department of Respiratory Medicine, Kumamoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
first enrollment 1)Squamous cell carcinoma 2)brain metastasis 3)Pregnant or breast-feeding females second enrollment 1)Interstitial pneumonia or pulmonary fibrosis on chest CT scans 2)History of EGFR-TKI, VEGF antibody allergic reaction. 3)Radiotherapy enforcement example for the brain 4)Brain metastasis expected bleeding 5)Active severe comorbidity disease. 6)History of hemoptysis 7)Uncontrollable hypertension 8)History of gastrointenstinal perforation or diverticulitis or fistula 9)Scheduled operation 10)Active concomitant malignancy 11)Pregnant or breast-feeding females 12)Inappropriate patients for this study judged by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to treatment failure after secondary enrollment
- Secondary Outcome Measures
Name Time Method Toxicity Response Rate for intracranial metastases Overall survival