The Exploratory Study to Evaluate Biomarkers in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer (J-TAIL-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 95
- 主要终点
- Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
研究概览
简要总结
This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.
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
- •Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.
- •<non-small cell lung cancer cohort>
- •Patients 20 years of age or older at the time of signed consent.
- •Patients with unresectable, advanced and recurrent non-small cell lung cancer.
- •Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use 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.
- •<extensive disease small cell lung cancer cohort>
- •Patients 20 years of age or older at the time of signed consent.
- •Patients with extensive disease small cell lung cancer.
- •Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use 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. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.
排除标准
- •<non-small cell lung cancer cohort>
- •Patients who are unsuitable for enrolment into the study by the investigator's judgment.
- •<extensive disease small cell lung cancer cohort>
- •Patients who are unsuitable for enrolment into the study by the investigator's judgment.
结局指标
主要结局
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
时间窗: Baseline, Predose of cycle 2 (each cycle is 21 days), and when immune-related adverse event occurs (through study completion, an average of 2 years 5 months)
Correlation between PD-L1 SNP and atezolizumab combination therapy
时间窗: Baseline
Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy
时间窗: Baseline
次要结局
未报告次要终点