Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT03399669
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03399669
Study Brief:
Protocol Section:
NCT03399669