Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in EGFR Mutation-Positive, Locally Advanced or Metastatic Chinese NSCLC Patients, Who Have Progressed From First-line EGFR-TKI Therapy (PISCES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Physician-reported clinical outcomes, PFS
研究概览
简要总结
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
详细描述
The objectives of this study are to assess molecular testing, treatment patterns, and associated clinical outcomes among patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed from first-line EGFR-TKI (tyrosine kinase inhibitor) therapy. This study is descriptive in nature and does not attempt to test any specific a priori hypotheses
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physician-reported clinical outcomes, PFS
时间窗: From enrolment to follow-up of up to 36 months
from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death
targeted therapy
时间窗: From enrolment to follow-up of up to 36 months
For each line of targeted therapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy
Time to initiate second line therapy from progression from 1L treatment
时间窗: From enrolment to follow-up of up to 36 months
Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment
chemotherapy
时间窗: From enrolment to follow-up of up to 36 months
For each line of chemotherapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy
immunotherapy
时间窗: From enrolment to follow-up of up to 36 months
For each line of immunotherapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy
Response rate
时间窗: From enrolment to follow-up of up to 36 months
Response rate reported by physician or judged by Recist1.1 after receiving any pattern of therapy
Physician-reported clinical outcomes, OS
时间窗: From enrolment to follow-up of up to 36 months
the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately)
local therapy
时间窗: From enrolment to follow-up of up to 36 months
For each line of local therapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy
palliative/supportive care
时间窗: From enrolment to follow-up of up to 36 months
Any palliative/supportive care received
次要结局
- Molecular testing turnaround time(From enrolment to follow-up of up to 36 months)
- Molecular testing laboratory type(From enrolment to follow-up of up to 36 months)
- mutation status(From enrolment to follow-up of up to 36 months)
- Molecular test outcome(From enrolment to follow-up of up to 36 months)
- Molecular testing rate(From enrolment to follow-up of up to 36 months)
- Molecular test type(From enrolment to follow-up of up to 36 months)
- reason for molecular testing(From enrolment to follow-up of up to 36 months)
- Type of treatments for CNS metastases(From enrolment to follow-up of up to 36 months)
- Molecular testing sample type(From enrolment to follow-up of up to 36 months)
- changes in testing rate over time(From enrolment to follow-up of up to 36 months)
- Molecular testing method of biopsy(From enrolment to follow-up of up to 36 months)
- reason for not performing a molecular test(From enrolment to follow-up of up to 36 months)
- mutation type(From enrolment to follow-up of up to 36 months)
- Time from progression date to molecular testing(From enrolment to follow-up of up to 36 months)
- histologic/phenotypic transformation(From enrolment to follow-up of up to 36 months)
- Brain metastases rate(From enrolment to follow-up of up to 36 months)
- Change in score from baseline for each QoL domain measured at each subsequent site visit(From enrolment to follow-up of up to 36 months)
- Change in score from baseline for overall QoL measured at each subsequent site visit(From enrolment to follow-up of up to 36 months)
- Overall CNS metastases rate(From enrolment to follow-up of up to 36 months)
- Leptomeningeal metastases rate(From enrolment to follow-up of up to 36 months)
- Date of treatments for CNS metastases(From enrolment to follow-up of up to 36 months)