NCT05583409尚未招募不适用
Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
Li Zhang1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have biopsy proven metastatic NSCLC (Stage IV).
- •Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
- •Age 18 to 75 years old.
- •Patients must have measurable disease at baseline.
- •The amount of metastatic focus <
- •ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.
- •Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
- •Patients must provide written informed consent to participate in the study.
排除标准
- •Patients who previously received radiotherapy to the primary site.
- •Patient can't tolerate radiotherapy or targeted therapy;
- •Pregnant or nursing women
研究组 & 干预措施
Osimertinib plus SBRT
Experimental
SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
干预措施: SBRT+Osimertinib (Radiation)
Osimertinib
Active Comparator
Osimertinib 80mg, po, Qd
干预措施: Osimertinib 80 MG (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
the time from the beginning of Osimertinib treatment to disease progression or death
次要结局
- OS(3 years)
研究者
Li Zhang
Professor
Tongji Hospital
研究点 (1)
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