T790M (detected by cobas EGFR Mutation Test v2) from the relapsed tumor after EGFR-TKI therapy.
Conditions
Interventions
Before osimertinib therapy, examination of FDG-PET and CT scan are performed and target lesions are determined. We measured the diameter of targeted lesions and maximum uptakes in each lesion (SUVmax)
Sponsors
Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.age>20 years old 2.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 3.At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 4.At least two weeks after prior EGFR-TKI therapy or 4 weeks after systemic anticancer therapy 5.Written informed consent 6.adequate hepatic and renal function. Laboratory findings within 7 days before entry described above were as follows; 1)hemoglobin level:more than 9.0g/dL 2)White blood cell:equal to or less than 15000/mm3 3) Neutrophil:more than 1500/mm3 4) Platelet:more than 100000/mm3 5) AST/ALT:equal to or less than 100 IU/L 6) Total bilirubin:equal to or less than 2.0mg/dL 7) Creatinine:equal to or less than 1.5mg/dL 8) Creatinine clearance:more than 50 mL/min(measured value or Cockcroft-Gault formula). 9) SpO2 >92 % 10) Contraceptive measures Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Male patients should be willing to use barrier contraception.
Exclusion criteria
Exclusion criteria: 1.past history of hypersensitivity to drugs; 2.Double cancers, 3.Severe complications (for example, heart failure, renal failure, liver failure, severe diabetes mellitus, etc.); 4.Active infection including hepatitis B, hepatitis C and HIV. 5.Interstitial lung disease detectable on chest radiography or past history of interstitial lung disease during prior EGFR-TKIs therapy; 6.Pleural, pericardial, or peritoneal effusion requiring drainage; 7.Active brain metastasis; 8.Pregnancy or female with planning pregnancy. 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 (urine or serum) pregnancy test prior to study entry 9.Any of the following cardiac criteria: -Mean resting corrected QT interval: >470 msec, -Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) -Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. 10. Treatment history of immune-check point inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the correlation between the SUVmax reduction rate and tumor size reduction rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the correlation between the SUVmax reduction rate and progression-free survival (PFS) in targeted lesions. | — |
Countries
Japan
Contacts
Public ContactTomonobu Koizumi
Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan, Department of Comprehensive Cancer Therapy
Outcome results
None listed