Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.
详细描述
This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.
Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
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
- •Non-small cell lung cancer diagnosed by histopathology or cytology;
- •Previous molecular pathology was EGFR sensitive mutation;
- •Stage IV;
- •ECOG score 0-2;
- •Prior to receiving the third generation of EGFR-TKI targeted therapy, and TKI targeted therapy showed limited progress;
- •According to RECIST1.1 standards, there are measurable or evaluable lesions
- •The patient has fully understood this study and voluntarily signed a written informed consent form;
- •The estimated survival time is more than 3 months.
排除标准
- •Histological or cytological confirmation of small cell lung cancer or squamous cell carcinoma at the first diagnosis;
- •The progression of the third generation EGFR-TKI suggests histological transformation.
研究组 & 干预措施
Study arm
Almonertinib plus metronomic oral vinorelbine
干预措施: Almonertinib and metronomic oral vinorelbine (Drug)
结局指标
主要结局
PFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
次要结局
- ORR(up to 12 months)
- DCR(up to 12 months)