JPRN-UMIN000022077已完成未知
Observational study on detecting EGFR T790M mutation with multiple modalities in cell free DNA from advanced non small cell lung cancer patients (WJOG8815LPS) - EGFR T790M mutation analysis with cfDNA from NSCLC patients
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Treatment history *Third-generation EGFR-TKI *Major surgery within 4 weeks of collection of plasma sample *Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of collection of plasma sample. 2.Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy. 3.Spinal cord compression or brain metastases 4.Any evidence, as judged by the investigator, etc., of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. 5.Refractory nausea and vomiting, chronic gastrointestinal diseases or inability to swallow the formulated product or previous bowel resection, etc. 6.Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD 7.Inadequate bone marrow reserve or organ function within 28 days after registration 8.Women who are breast-feeding 9.Synchronous or metachronous (within 2 years) malignancies. 10.Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.
研究者
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