ACTRN12613000739718终止未知
EGFR Mutation Blood Test Evaluation and Assessment of Changes in Sensitivity Resulting from Initiation of FirstLine Treatment of Advanced Adenocarcinoma of the Lung Diagnostic (EMERALD) Study
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •For inclusion in the study subjects should fulfil the following criteria:
- •1. Provision of informed consent prior to any study specific procedures
- •2. Stage IIIB or IV adenocarcinoma of the lung
- •3. Age > 18 years old
- •4. Have had a lung tissue biopsy that is archived and available for EGFR gene testing or be a candidate for a new biopsy
- •5. Considered clinically suitable for EGFR TKI therapy or chemotherapy as standard first line treatment
- •6. WHO or ECOG Performance Status equal or less than 2 and life expectancy is greater than or equal to12 weeks.
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2. Previous enrolment in the present study
- •3. Participation in another clinical study with any investigational product/device during the last 3 months
- •4. Pregnancy or breast feeding (women of child-bearing potential)
- •5. Prior systemic cytotoxic chemotherapy within 6 months
- •6. Radiation therapy within 4 weeks prior to provision of consent
- •7. High risk for poor compliance with therapy or follow-up as assessed by investigator
- •8. Any evidence of severe or uncontrolled diseases eg, unstable or uncompensated respiratory, cardiac (including arrhythmias), hepatic or renal disease.
- •9. Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood in previous 4 weeks)
- •10. History of bleeding diathesis (i.e. disseminated intravascular coagulation (DIC), clotting factor deficiency etc) or long-term anticoagulant therapy (other than anti-platelet therapy and low dose warfarin).
- •11. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
- •12. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the target lesion
- •13. Active, uncontrolled infection
- •14. Previous or current treatment with an EGFR TKI
研究者
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