A longitudinal study evaluating molecular changes associated with resistance to first and third (AZD9291) generation EGFR TKIs in patients with EGFR mutant NSCLC using liquid biopsy - Liquid biopsy as a tool to evaluate resistance to First and Third (AZD9291) Egfr Tkis in EGFR mutant

Hellenic Oncology Research Group0 个研究点目标入组 48 人开始时间: 2016年4月13日最近更新: 2023年1月9日

试验速览

暂无简介。

•For inclusion in the study subjects should fulfill the following criteria:
•1. Age >18 years
•2. Both sexes
•3. Histologically or cytologically documented NSCLC
•4. Stage IIIB not amenable to radical therapy or stage IV
•5. Presence of EGFR activating mutations (exon 19 deletion or L858R in exon 21)
•6. First or second line treatment with EGFR TKIs
•7. Performance status (ECOG): 0-1
•8. Measurable or evaluable disease
•9. Adequate organ function tests (Hb=10g/dL, WBC=3.0 x 109/L , neutrophils count=1.5 x 109/L, platelets=100 x 109/L, Creatinine clearance=50 mL/min, Total bilirubin=1.5 X UNL, AST, ALT and ALP=2.5 x UNL)
•10. Normal QT interval in ECG
•11. CNS metastases are allowed provided that they have been irradiated and the patient is clinically stable
•12. Women of child bearing potential and all men will be required to use adequate contraceptive measures
•13. Life expectancy of at least 3 months
•14. Written informed consent
•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 48
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
•1. History of serious drug allergy
•2. Refractory nausea, vomiting and chronic gastrointestinal diseases
•3. Any of the following cardiac criteria:
•Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
•Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
•Any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
•4. Severe or uncontrolled systemic liver disease, including those with known hepatitis B, hepatitis C, and Human Immunodeficiency virus (HIV) infection
•5. Interstitial lung disease or pulmonary fibrosis
•6. Pregnancy, lactation or other concomitant serious medical condition
•7. Other concurrent active malignancy

发起方

Hellenic Oncology Research Group