JPRN-UMIN000031584已完成3 期
Phase III study of ramucirumab plus docetaxel versus atezolizumab for PD-L1-negative or weakly positive advanced non-small-cell lung cancer after disease progression on platinum-based therapy. (EMERALD study) (WJOG10317L) - RAM+DOC vs Atezo (EMERALD study)(WJOG10317L)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
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) Active multiple primary cancers. 2) A history of autoimmune disease. However, the following cases are allowed to register. -Controlled type 1 diabetes with stable insulin usage. -Hypothyroidism that can be managed with hormone replacement therapy 3) Requires systemic adrenal steroid (equivalent of prednisone exceeding 10 mg/day) or another immunosuppressant within 14 days of the registration. 4) History of serious or non-healing wounds, ulcers, or fractures that are serious within 28 days before registration. 5) History of hypersensitivity to drugs containing polysorbate 80. 6) History of serious hypersensitivity. 7) Presence of local or systemic active infection 8) CT findings clearly show interstitial pneumonia. 9) Hemoptysis within two months of registration (>= 1/2 tsp). 10) History of digestive tract perforation, peptic ulcer, diverticulosis, or fistula within six months before registration. 11) History or the presence of intestinal obstruction, inflammatory bowel disorder, extensive intestinal resection (hemicolectomy or extensive small bowel resection due to chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 12) History of uncontrollable thrombosis or embolism. 13) Vasculitis, grade 3 or worse gastrointestinal bleeding, or clinically serious bleeding within three months of registration. 14) Arterial thrombosis such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within six months before trial treatment. 15) Congestive heart failure of New York Heart Association (NYHA) Class II or worse. 16) Diabetes that cannot be controlled even with an appropriate treatment. 17) Hypertension that cannot be controlled with a standard medical treatment (systolic blood pressure of 150 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher).
研究者
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