Osimertinib as First Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer: the Experience of the Hellenic Cooperative Oncology Group (HeCOG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The present study will evaluate the use of osimertinib as 1st line therapy for patients with advanced EGFR positive non-small cell lung cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.
详细描述
This will be an observational, multicentric, retrospective/ prospective analysis of patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy. The patient data will be collected at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology during scheduled patient clinical visits, from February 2020 for a total period of three years. The biological material obtained from the patients of this analysis will be possibly used in a future translational study as an exploratory analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •men or women of 18 years or older that live in Greece
- •histologically or cytologically confirmed, advanced EGFR positive non-small cell lung cancer
- •untreated patients for advanced NSCLC
- •patients who are expected to receive osimertinib regardless of their enrollment in the study
- •signed written informed consent
排除标准
- •patients with cancer other than NSCLC that require treatment
- •pretreated patients for NSCLC
- •patients that receive or are expected to receive or have received an investigational drug/product/intervention
结局指标
主要结局
progression-free survival (PFS)
时间窗: through the completion of the study, up to 2 years
the time from treatment initiation to either the first documented disease progression or death from any cause
次要结局
- quality of life data(through the completion of the study, up to 2 years)
- Safety profile and toxicity(through the completion of the study, up to 2 years)
- overall survival (OS)(through the completion of the study, up to 2 years)
- overall response rate (ORR)(through the completion of the study, up to 2 years)
- health economics(through the completion of the study, up to 2 years)
- second progression-free survival (PFS2)(through the completion of the study, up to 2 years)