First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of treatment related adverse events (AEs)
研究概览
简要总结
This study (FLOWER) will investigate effectiveness, safety, progression patterns and clinical management of untreated advanced NSCLC patients receiving fist-line osimertinib in the real-world.
详细描述
FLOWER is a real-world, prospective, observational study enrolling patients with histological and/or cytological diagnosis of EGFR-mutant aNSCLC, receiving first-line treatment with the third-generation EGFR-TKI, osimertinib. All the patients received osimertinib at the recommended dose of 80 mg, orally, once a day. Dosing interruptions or reductions required, based on individual tolerability, were managed according to clinical practice in compliance with label indications.
The FLOWER study aims at evaluating effectiveness, safety, progression pattern and clinical management of untreated EGFR-mutant aNSCLC patients in the real-world.
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
- •histological confirmed diagnosis of NSCLC and EGFR mutation in exon 18-21;
- •locally advanced inoperable or metastatic disease (stage III and IV according to 8th edition of the TNM classification for lung cancer);
- •first line treatment with the third generation EGFR TKI, osimertinib;
- •age >18 years
- •written informed consent
排除标准
- •Patients who receive study drugs in clinical trials will be excluded.
研究组 & 干预措施
Untreated EGFR-mutant advanced non-small-cell lung cancer patients
干预措施: Osimertinib 80 MG (Drug)
结局指标
主要结局
Rate of treatment related adverse events (AEs)
时间窗: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
to evaluate safety of patients treated with osimertinib in the real-world
Median time to discontinuation (mTTD)
时间窗: The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months
To evaluate the effectiveness of osimertinib in the real-world
Rate of dose reduction and temporary or definitive treatment interruption due to AE
时间窗: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
to evaluate safety of patients treated with osimertinib in the real-world
次要结局
- Median progression free survival (mPFS)(The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months)
- Median overall survival (mOS)(The primary analysis of mOS will occur when all patients have had the opportunity to be treated for 6 months)
- Overall response rate(The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months)
- Progression pattern(The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months)