advanced / recurrent non-small cell lung cancer (NSCLC)
Conditions
Interventions
Osimertinib 80mg, o.d. is orally administered. Administered until PD (or the meeting of discontinuation criteria).
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with stage IIIB/IV whose stage was histologically or cytologically confirmed as non-small-cell lung cancer and post-operative recurrence 2.Patients with recurrence after the effect of higher than SD was observed or not effective (less than stable disease (SD) in best overall response according to RECIST) by treatment of EGFR-TKI (e.g.: such as erlotinib, gefitinib, afatinib) for non-small-cell lung cancer 3.T790M positive after disease progression 4.Patients capable of treatment with oral medicine 5.Patients have at least one measurable lesion according to RECIST criteria 6.Performance Status(ECOG) 0-1 7.In principle, Patients capable of participating this study under at least 2 weeks admission to the hospital or corresponding management 8.Patients are >75 years of age (age at the time of enrollment). 9.Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal 10.Patients with life expectancy of at least 3 months
Exclusion criteria
Exclusion criteria: 1.Patients who have treatment history of osimertinib and other 3rd generation EGFR-TKI. 2.Patients with pulmonary disorders such as Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis and drug-induced pneumonia. 3.Patients with infectious disorder need for intravenous injection of antibacterial drug and antimycotics. 4.Patients unable to swallow oral medications. 5.Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4. 6.Patients currently receiving checkpoint inhibitor or with treatment history. 7.Patients with any of the following cardiac criteria: 1)Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec 2)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) 3)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 8.Patients who are pregnant, nursing or possibly pregnant. 9.Patients with brain metastasis accompanying symptoms. 10.Patients with active double cancer. 11.Patients with uncontrollable diabetes mellitus. 12.Patients who have complications to be clinical problem (Such as uncontrollable cardiac disease, severe cardiac arrhythmia to need medical treatment, sustained serious diarrhoea)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) Overall Survival (OS) Disease Control Rate (DCR) Safety Positive/negative concordance rate of T790M between tumour tissue or humoral specimen and plasma DNA | — |
Countries
Japan
Contacts
Public ContactAKIRA NAKAO
Faculty of Medicine, Fukuoka University Department of Respiratory Medicine
Outcome results
None listed