Survey on the Treatment Reality of Patients With EGFR Mutation-positive Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overall survival of the patients.
研究概览
简要总结
According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However, the real situation and the reason are not clarified.This observational study collects the data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of approximately 20 facilities in Japan and observes the treatment reality of EGFR gene mutation-positive NSCLC.
详细描述
Study Site(s), number of subjects and countries planned Approximately 2000, Advanced Non Small Cell Lung cancer (aNSCLC) patients who fulfil the inclusion/exclusion criteria will be recruited by 10 to 20 investigational sites in Japan.
Total planned Study period Estimated date of first subject in June , 2015 Estimated date of last subject in November , 2015 Estimated date of data base lock December, 2015 Estimated date of first subject in for investigation of survival January, 2016 Estimated date of last subject in for investigation of survival March, 2016 Estimated date of data base lock for investigation of survival March, 2016
Medicinal Products (type, dose, mode of administration) and concomitant medication Not applicable Study Rationale As its benefits in EGFR mutation-positive patients have been reported, EGFR-TKI is now recommended by guidelines as standard first-line therapy for EGFR mutation-positive patients. Back then when concomitant use of platinum medication and 3rd-generation cytocidal drug was the standard therapy, treatment was of very poor prognosis, 8 to 10 months in terms of median overall survival, and a 1-year survival rate of 30% to 35%. Then, gefitinib was approved in July 2002. Takano et al. reported that survival among patients with EGFR mutation-positive non-small cell lung cancer has been getting longer after approval of gefitinib. The overall survival of patients with EGFR mutation-positive non-small cell lung cancer was 27.7 months in gefitinib group of Study North East Japan (NEJ) 002 reported by Inoue et al. in 2013, 34.8 months in gefitinib group of Study West Japan Oncology Group (WJOG) 3405 reported by Yoshioka et al. in 2014, 36.3 months in patients receiving erlotinib in Study Japan Oncology (JO) 22903 reported by Katakami et al. in 2014, and 46.9 months in afatinib group and 35.8 months in chemotherapy group of the Japanese subset in Study Lux-Lung3 reported by Kato. According to recent reports, overall survival tends to be prolonging, but the actual situation and the reason for such tendency has not been revealed.
Thus, we planned the present study, which clarify the prognosis, patient characteristics and treatment regimen of the patients with EGFR mutation positive NSCLC to provide useful information in order to promote individualized therapy for the patients with EGFR mutation positive NSCLC.
Study Objectives The primary objective of this study is intended to reveal the characteristics of and reality of the treatment and survival among patients with EGFR mutation-positive advanced/recurrent non-small cell lung cancer. The primary objective, secondary objective and exploratory objective of the study are as follows.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EGFR mutation-positive progress recurrent non-small cell lung cancer subject.
- •Subjects who commenced on first-line treatment between January, 2008 and December 2012.
排除标准
- •Patients has a treatment history with the drug which was not approved for marketing authorization as of 31th December , 2014
- •Person who were planning and/or getting involved in this survey. (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous enrolment in the present study.
- •Patient was not evaluated to be appropriate for study enrolment by the investigators
结局指标
主要结局
Overall survival of the patients.
时间窗: Up to 3 monthes. Data will be collected retrospectively from medical records.Survival status as of the end of December 2014, date of death or date of last follow-up of survival.
次要结局
- Overall survival by patient background(Up to 3 monthes. Data will be collected retrospectively from medical records.)
- Time to Treatment Failure (TTF) of Gefitinib treatment(Up to 3 monthes. Data will be collected retrospectively from medical records.)
- Overall survival by treatment sequence(Up to 3 monthes. Data will be collected retrospectively from medical records.)
- Treatment time by treatment category(Up to 3 monthes. Data will be collected retrospectively from medical records.)