Osimertinib combined bevacizumab in untreated epidermal growth factor receptor mutaeted non-small-cell lung cancer patients with malignant pleural and/or pericardial effusion -phase II trial
- Conditions
- advanced/recurrent non-small cell lung cancer (NSCLC)
- Registration Number
- JPRN-UMIN000028071
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 31
Not provided
1.Patients whose chest drainage is no problem for pleural effusion,but who have pleurodesis. 2.Patients with pulmonary disorders such as idiopathic pulmonary fibrosis,interstitial pneumonia, pneumoconiosis,active radiation pneumonitis and drug-induced pneumonia. 3.Anamnesis and complication of hemoptysisor the following bloody sputum. bloody sputum which occurs continuously bloody sputum which needs the continuous administration of oral hemostatics bloody sputum necessary for homostatic injection. 4.Patients with cavity and tumor invasion to large vessels. 5.Infectious disorder need for intravenous injection of antibacterial drug and antimycotics. 6.Patients with corneal ulcer.7.Patients with any of the following risk of QTc prolongation: Mean resting mean corrected QT interval >470msec. Any clinically important abnormalities in rhythm,conduction or morphology of resting ECG. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events. 8.Patients who are pregnant,nursing or possibly pregnant. 9.Patients with brain metastasis accompanying symptoms. 10.Active double cancer. 11.Patients with uncontrollable diabetes mellitus. 12.Patients who have complications to be clinical problem. 13.Patients judged as severe or uncontrollable systemic disease by investigators. For example,patients is judged by investigators that the participation in the study is undesirable or that the compliance of the protocol is difficult by uncontrollable hypertension and active hemorrhagic diathesis or hepatitis B,hepatitis C and active infections such as human immunodeficiency virus infection. 14.Patients with anamneses such as refractory nausea and vomiting,chronic digestive organ disease or pharmaceutical preparation aphagia,or gastroeneterectomy that may remarkably influence osimertinib absorption. 15.Patients whose wound healing cannot be confirmed. 16.Patients without intention to prevent pregnancy during a study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 year Progression free survival rate (1-year PFS rate)
- Secondary Outcome Measures
Name Time Method Rresponse rate (RR) Progression free survival (PFS) Overall survival (OS) Safety Pleural or pericardial drainage free survival