An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
研究概览
简要总结
This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.
详细描述
This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.
EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
- •Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
- •No previous/ ongoing treatment for NSCLC at the moment of recruitment
排除标准
- •Squamous NSCLC cytologically confirmed subtype of cancer
- •Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
- •Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing
结局指标
主要结局
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
时间窗: up to 18 months
次要结局
- EGFR mutations profile in cytology and/or histology (depending on the availablility of samples) and plasma samples at the time of every progression or in 1.5 year follow up in case of no progression(up to 18 months)
- Characteristics of the 1st line and subsequent lines of antitumor therapy(up to 18 months)
- Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.(up to 18 months)
- Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)(up to 18 months)
- Disease information/diagnostic procedures(up to 18 months)