EUCTR2020-003025-37-NL进行中（未招募）1 期
COMBINING AFATINIB AND CONCURRENT CHEMOTHERAPY, FOLLOWED BY OSIMERTINIB AND CONCURRENT CHEMOTHERAPY, IN UNTREATED EGFR POSITIVE NSCLC TUMORS - combination
VU University Medical Center0 个研究点目标入组 21 人开始时间: 2020年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed NSCLC, positive for EGFR exon 19 deletion or EGFR exon 21 L858R
- •WHO PS 0-2
- •Be willing and able to provide written informed consent for the trial.
- •Be above 18 years of age on day of signing informed consent.
- •Patients must have radiological measurable disease
- •Demonstrate adequate organ function, as deemed acceptable by the treating physician in the context of metastatic NSCLC:
- •Leukocytes = 3,000/mm3
- •Absolute neutrophil count (ANC) = 1500/mm3
- •Platelet count = 100,000/mm3
- •Hemoglobin = 6 mmol/L
- •Creatinine = 1.5 x ULN or creatinine clearance (CrCl) =40 mL/min (if using the Cockcroft-Gault formula below):
- •Female CrCl = [(140 - age) x weight x 0.85]/(0.85 x creat in mmol/L)
- •Male CrCl = [(140 - age) x weight x 1.00]/(0.81 x creat in mmol/L)
- •Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome)
- •AST and ALT = 3 times the upper limit of normal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Inability to provide informed consent
- •Inability to take study medications
- •Patients with CNS metastases
- •Prior EGFR TKI or platinum-doublet therapy for advanced stage NSCLC. Prior (neo)adjuvant treatments are allowed when the last administration is one year or more.
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Active infection requiring systemic therapy.
- •Active Hepatitis B or C.
- •Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit.
研究者
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