KCT0009390尚未招募Unknown
An open label, multicenter, single arm, exploratory study to determine the detection rate of EGFR T790M from bronchial washing fluid (BWF) in patients with non-small cell lung cancer (NSCLC) who failed 1st line EGFR-tyrosine kinase inhibitor (TKI) treatment and to confirm the therapeutic efficacy of Leclaza® in the T790M-positive patients
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Adult males or females aged 18 years or older.
- •2. Patients diagnosed with locally advanced or metastatic non-small cell lung cancer.
- •3. Patients diagnosed with histologically or cytologically confirmed mEGFR (+) adenocarcinoma of the lung.
- •4. Patients who have received treatment with a first-line EGFR-TKI approved in the country.
- •5. Patients who have experienced recurrence while on first-line EGFR-TKI therapy after the start date of the study.
- •6. Patients for whom the response to first-line EGFR-TKI therapy can be evaluated.
- •7. Patients who have provided consent for and undergone tissue biopsy, blood sample collection, and bronchoscopy for EGFR mutation confirmation.
- •8. Patients who have provided written consent for participation in the study.
排除标准
- •Patients who discontinued treatment with first-generation or second-generation EGFR-TKIs for reasons other than disease progression.
- •Patients for whom medical records are not available for review.
- •Patients who cannot undergo all tests required for selection criterion 7) due to overall health status or other reasons.
- •Patients for whom any form of intervention for cancer treatment occurred between bronchial washing fluid and blood sample collection.
- •Individuals who have not consented to undergo testing and provide samples.
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