NCT06422546招募中不适用
A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC
Beijing Cancer Prevention & Treatment Society1 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2022年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- changes in EGFR gene mutations
研究概览
简要总结
To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC
详细描述
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥18 years old male or female
- •Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
- •Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
- •EGFR positive in blood or tissue tested in local laboratory;
- •Sufficient blood samples can be provided for molecular detection;
- •Signed informed consent forms are available.
排除标准
- •Patients were unable to collect plasma samples at baseline;
- •The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
- •The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
结局指标
主要结局
changes in EGFR gene mutations
时间窗: baseline and 3 weeks after oxitinib treatment
To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment
次要结局
- Characteristics of EGFR gene mutation and efficacy of oxitinib treatment(baseline and 3 weeks after oxitinib treatment)
研究者
研究点 (1)
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