JPRN-UMIN000017069已完成3 期
Randomized phase III study comparing erlotinib plus bevacizumab to erlotinib alone in patients with previously untreated non-small cell lung cancer harboring EGFR mutation (NEJ026) - Randomized phase III study of erlotinib + bevacizumab vs erlotinib (NEJ026)
orth East Japan Study Group (NEJSG)0 个研究点目标入组 214 人开始时间: 2015年4月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Exon 20 T790M mutation status, detected with PCR, is active. Have received (2)Have symptomatic brain metastasis (3)Have a history of multiple malignancies within 5 years (4)History of pulmonary hemorrhage or hemoptysis as defined below; 1)Hemosputum continuing for more than 1 week within 1 year before enrollment. 2)Have had or require continuous oral administration of hemostat 3)Have had or require injectable administration of hemostat (5)Evidence of bleeding diathesis or hemoptysis (6)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging (7)Evidence of tumor invading segmental bronchus (8)Uncontrolled pleural, ascites effusion or cardiac effusion (9)Having a history or serious complications as bellows; 1)SVC syndrome complication 2)Spinal cord compression 3)Having a history of serious symptomatic cerebrovascular disease within 1 year before enrollment 4)Unrecovered fracture or severe injury 5)Have severe infection 6)Having a history or evidence of ILD complication on imaging or lung infection (except history of radiation pneumonitis in radiation area) 7)Have gastrointestinal dysfunction as follows; <1>Impossible to take drugs orally <2>Need intravenous feeding <3>Have malabsorption by surgery <4>Have active peptic ulcer 8)Have severe corneal disease complication 9)Have severe heart disease complication 10)Have diverticulitis 11)Have ever had a history of gastrointestinal perforation within 1 year prior to registration 12)Have severe neurological deficit or mental disorder 13)Have active hepatic disease (10)Surgery planned in trial period (11)Have a history of severe allergy of other monoclonal antibody drugs (12)Have a history of EGFR TKI or anti-angiogenesis drug administration (13)Pregnant or breast-feeding woman (14)Patients who have no will to contraception (15)Patients whose participation in the trial is judged to be inappropriate by the doctor
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