Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance - BAGEL study

BAGEL study group0 个研究点目标入组 90 人开始时间: 2014年5月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

BAGEL study group