JPRN-jRCTs061180006已完成2 期
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 - AfaBev-CS
Kiura Katsuyuki0 个研究点目标入组 100 人开始时间: 2018年11月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
Compared with afatinib monotherapy, afatinib plus bevacizumab did not prolong the PFS of untreated patients with EGFR-mutated non-squamous NSCLC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Non-squamous non-small cell lung cancer
- •2) EGFR exon19 deletion or L858R
- •3) stage IIIB or IV or recurrence
- •4) chemotherapy naive
- •5) ECOG PS 0 or 1
- •6) With measurable target lesion or unmeasurable lesion as per RECIST ver1.1
- •7) With adequate organ function
- •8) Provided written informed consent
排除标准
- •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 syndrome, interstitial pneumonia etc.)
- •11) History of serious drug allergies
- •12) Pregnancy, breast feeding, or hesitation in contraception
- •13) Other conditions not suitable for this study
研究者
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