A Single Arm, Prospective, Open Clinical Study of Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC With EGFR Mutation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 2-year overall survival rate
研究概览
简要总结
This is a Prospective, open, single arm study to evaluate the efficacy and safety of the almonertinib combined with concurrent chemoradiotherapy in unresectable stage III NSCLC with EGFR mutation
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
- •Age ≥18, male or female.
- •Patients must provide written informed consent to participate in the study.
- •Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).
- •Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).
- •Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.
- •ECOG score 0-1
- •Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy
排除标准
- •Patients progress in 3 months after almonertinib treatment
- •Patient can't tolerate radiotherapy or targeted therapy
- •Pregnant or nursing women
研究组 & 干预措施
Almonertinib group
All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.
干预措施: Almonertinib (Drug)
结局指标
主要结局
2-year overall survival rate
时间窗: 2 years
The 2-year overall survival rate was defined as the rate of death within 2 years
次要结局
- Overall survival(5 years)
- Progression-free survival(3 years)
研究者
Yuan Chen
Head of chest oncology, Professor
Tongji Hospital