Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Samsung Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed stage IIIB/IV or recurrent NSCLC with activating EGFR mutation in exon 18 through exon 21 except T790M
Patients who achieved complete/partial response more than 4 months or stable disease more than 6 months with first-line or second line gefitinib
Patients who experience disease progression by RECIST 1.1 criteria
Age ≥ 18years
ECOG performance status of 0 to 2
Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL, CCr ≥ 50mL/min
Baseline adverse event of gefitinib ≤ Grade 2
Written informed consent form
You may not be if
Prior treatment with EGFR TKI
Patients who required dose reduction of gefitinib
Surgery undertaken less than 4 weeks before the study
Localized radiotherapy unless completed more than 2 weeks before the study
Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method (hormonal or barrier methods))
Uncontrolled symptomatic brain metastasis
Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Concomitant use of CYP3A4 inducers/inhibitors
Prolonged QT interval in ECG (QTc \>450 msec)
Patients who cannot take a medicine orally or who have a gastrointestinal absorption disorder
Clareo Health | The Continuation of Gefitinib Treatment Beyond Progression in Non-small Cell Lung Cancer Patients With EGFR Mutation
