First-line Atezolizumab Plus Chemotherapy in Patients With Extensive-stage Small-cell Lung Cancer:a Real World,Single Arm,Multicenter,Prospective Study in China
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
The study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events.
详细描述
In 2018,the results of IMpower 133 were reported on WCLC.Meanwhile,the data was published in NEJM.Atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by NCCN guidelines quickly.
Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China.
Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
- •No prior systemic treatment for ES-SCLC
- •18-80 years old, or more than 10 months of expected natural survival;
- •Eastern Cooperative Oncology Group performance status of 0 or 1 or 2
- •Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function
- •Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
- •The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- •Patients or family members cannot understand the conditions and goals of this study.
- •The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule
研究组 & 干预措施
Arm B
100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w
干预措施: Chemotherapy Drugs, Cancer (Drug)
Arm A
200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w
干预措施: Chemotherapy Drugs, Cancer (Drug)
结局指标
主要结局
OS
时间窗: Baseline until death from any cause(up to approximately 23 months)
Duration of overall survival
irAE
时间窗: Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers
Percentage of participants with Immune-related
次要结局
- PFS(Baseline until PD or death,whichever occurs first(up to approximately 23months)])
- Treatment related biomarkers(Baseline until PD or death,whichever occurs during this period(up to approximately 23months)])
- Quality of Life (QL)(Baseline until PD or death,whichever occurs during this period(up to approximately 23months)])
- ) Score(Baseline until PD or death,whichever occurs during this period(up to approximately 23months)])
研究者
Li Zhang
Professor,Chief physician
Peking Union Medical College Hospital