Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II study
Phase 2
- Conditions
- on-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000027432
- Lead Sponsor
- Okayama University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) EGFR exon20 T790M 2) Symptomatic brain metastasis 3) Meningitis 4) Other cancers 5) Hemoptysis 6) Hemorrhagic tendency (coagulation disorder etc.) 7) Invasion to measure artery or vessel 8) Invasion to mucosa of bronchus 9) Pleural effusion, ascites or pericardial effusion requiring drainage 10) With severe complication (SVC symdrome, interstinal neumonia etc.) 11) History of serious drug allergies 12) Pregnancy, breast feeding, or hesitation in contraception 13) Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Response rate, Disease control rate, Relative dose intensity, Quality of life, Adverse events