NCT04501497已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,221
- 试验地点
- 148
- 主要终点
- 12 months survival rate
研究概览
简要总结
This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.
详细描述
Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)
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
- •< 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 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.
- •<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 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
- •< non-small cell lung cancer cohort> (1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
- •<extensive disease small cell lung cancer cohort>
- •(1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
结局指标
主要结局
12 months survival rate
时间窗: Baseline up to 12 Months
Percentage of participants alive 12 months after initiation of treatment
次要结局
- Overall Survival(Up to death (up to 3 years))
- 6 moths survival rate(Up to 6 months)
- 18 moths survival rate(Up to 18 months)
- Progression-Free Survival(PFS)(Up to disease progression or death whichever occurs first (up to 3 years))
- Time to treatment failure (TTF)(Up to 3 years)
- Post-treatment transfer rate(Up to post-treatment is started (up to 3 years))
- Objective Response Rate(ORR)(Up to disease progression or death whichever occurs first (up to 3 years))
- Duration of Response(DOR)(From date of first objective response up to disease progression or death whichever occurs first (up to 3 years))
- Disease Control Rate(DCR)(Up to 3 years)
- Percentage of Participants with adverse events(Adverse Reactions)(Up to 3 years)
- Comprehensive geriatric assessment (G8)(At baseline)
研究者
研究点 (148)
Loading locations...
相似试验
已完成
1 期
A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid TumorsSolid TumorNCT02715531Hoffmann-La Roche243
已完成
不适用
A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)Non-small-Cell Lung CancerNCT03645330Chugai Pharmaceutical1,026
已完成
不适用
A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial ChemoembolizationUnresectable Hepatocellular CarcinomaNCT06503250Hoffmann-La Roche113
招募中
2 期
A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB TrialRecurrent GlioblastomaNCT06069726Duke University80
已完成
2 期
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT02031458Hoffmann-La Roche667