Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Response Rate as defined by RECIST 1.1
研究概览
简要总结
Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.
In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point).
详细描述
Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.
In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point). All the patients will be followed for 2 years.
The imaging modality used for RECIST v1.1 assessments will be PET-CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
研究组 & 干预措施
Tagrisso 80 mg
80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks.
干预措施: Tagrisso (Drug)
结局指标
主要结局
Overall Response Rate as defined by RECIST 1.1
时间窗: 12 weeks
assessed by PET-CT
次要结局
- Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy(2 years)
- mPFS measured by Kaplan-Meier method.(2 years)
研究者
Nir Peled
Head of Oncology
Shaare Zedek Medical Center