KCT0003243已完成未知
Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy
Koera University Guro Hospital0 个研究点目标入组 69 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Males or females = 19 years of age
- •2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) =6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood.
- •3. Patient with at least one measurable lesions according to RECIST v 1.1
- •4. Expected life expectancy = 12 weeks
- •5. Eastern Cooperative Oncology Group(ECOG) performance status = 2
- •6. Patients who have proper hematologic, renal and hepatic functions as follows:
- •Absolute neutrophil count(ANC) = 1,500/mm³
- •platelets = 100,000/mm³
- •Hemoglobin = 9g/dL
- •Total bilirubin = 1.25 X UNL
- •Aspartate aminotransferase(AST or SGOT) and alanine aminotransferase(ALT or SGPT) = 3.0 X UNL (if liver metastasis =5.0 X UNL)
- •Alkaline phosphatase = 2.5 X UNL (if liver metastasis =5.0 X UNL)
- •Serum creatinine = 1.5mg/dL
- •7. patients who are willing to comply with study procedure and voluntarily provide informed consent with signature
排除标准
- •1. Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ(CIS) cervical cancer within the last 5 years
- •2. Patients with brain metastasis except for the followings:
- •- Asymptomatic and stable brain metastases for which local treatment has been given: corticosteroids treatment isn't requiured for at least 2 weeks before starting the study treatment.
- •3. Patients currently receiving palliative radiation therapy or have toxicities from radiation therapy at screening.
- •4. Patients with clinically active history of interstitial lung disease(ILD), Drug induced ILD, Radiation pneumonitis
- •5. Patients with clinically significant cardiovascular disease or myocardial infarction within the past 12 months.
- •6. Patients with active infection or severe systemic disease that are difficult to include in this study
- •7. Patients who received radiation therapy to target lesion of this study.
- •8. Patients who had major operation within 4 weeks before starting the study treatment and were not fully recovered.
- •9. Patients who were administered other study drugs within 4 weeks before starting the study treatment
- •10. Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive pregnancy test prior to study entry
- •11. Patients who are difficult to include in this study in accordance with the investigator’s judgment
- •12. Patients with histories of hypersensitivity to investigational product(IP) or any components of the agent
- •13. Patients with any of the following genetic predispositions including galactose intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose malabsorption
- •14. Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration
- •15. Patients who are difficult to include in this study in accordance with the investigator’s judgment due to severe adverse effects during previous EGFR TKI treatment
研究者
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