Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance
- Conditions
- non small cell lung cancer
- Registration Number
- JPRN-UMIN000013586
- Lead Sponsor
- BAGEL study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Not provided
1) History of drug induced interstitial pneumonia or radiation pneumonitis that need steroid therapy. Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT 2) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) 3) central nervous system metastases 4) spinal cord compression 5) Active concomitant malignancy 6) Currently have or have a history of hemoptysis 7) bleeding tendency (coagulation disorder) 8) Patients receiving therapeutic anticoagulation 9) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management) 10) History of gastrointestinal perforation 11) History of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; active gastrointestinal ulcer, acive psychological disorders 12) Clinically significant drug allergy 13) Serious concomitant active infection 14) Receiving systemic corticosteroid therapy within 2 weeks of registration 15) Major surgery within 3 weeks of registration, radiotherapy within 2 weeks of registration 16) Pregnant or breast-feeding woman 17) Not suitable for participating in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method