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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03424759
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic or recurrent stage IV NSCLC with activating EGFR mutation other than deletion in exon 19, L858R, T790M and insertion in exon 20
* metastatic or recurrent NSCLC
* Be 19years of age on day of signing informed consent
* ECOG performance status of 0 to 2
* At least one measurable lesion by RECIST 1.1(The part of radiation treatment in the palliative setting is excluded.)
* Untreated asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
* At least 2 weeks later after whole brain radiotherapy or at least 4 weeks later after palliative thoracic radiotherapy
* Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; Hb \> 9.0g/dL; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 2.5 ULN if no demonstrable liver metastases or \< 5 UNL in the presence of liver metastases, CCr ≥ 50mL/min
* Written informed consent form
Exclusion Criteria:
* Prior treatment with EGFR TKI
* Major surgery undertaken less than 4 weeks before the study
* Localized palliative 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 adequate contraceptive method)
* 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, or well-treated thyroid cancer
* Concomitant use of CYP3A4 inducers/inhibitors
* Prolonged QT interval in ECG (QTc \>450 msec)
* Prior history of interstitial lung disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03424759
Study Brief:
Protocol Section:
NCT03424759