NCT03645330已完成不适用
Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,026
- 试验地点
- 198
- 主要终点
- 18 months survival rate
研究概览
简要总结
This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.
详细描述
Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 20 years of age or older at the time of signed consent.
- •Patients with locally advanced or metastatic non-small cell lung cancer.
- •Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.
- •Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.
排除标准
- •Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.
结局指标
主要结局
18 months survival rate
时间窗: Baseline up to 18 Months
Percentage of participants alive 18 months after initiation of treatment
次要结局
- 12 months survival rate(Up to 12 months)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire(Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years))
- 24 months survival rate(Up to 24 months)
- Progression-Free Survival(PFS)(Up to disease progression or death whichever occurs first (up to 4 years))
- Duration of Response(DOR)(From date of first objective response up to disease progression or death whichever occurs first (up to 4 years))
- Time to treatment failure (TTF)(Up to 4 years)
- Objective Response Rate(ORR)(Up to disease progression or death whichever occurs first (up to 4 years))
- Disease Control Rate(DCR)(Up to 4 years)
- Percentage of Participants with adverse events(Adverse Reactions)(Up to 4 years)
- Overall Survival(OS)(Up to death (up to 4 years))
研究者
研究点 (198)
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