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:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT02146118
Eligibility Criteria:
Inclusion Criteria:
* 1\. Histological or cytologic diagnosis of stage IV lung adenocarcinoma and confirmed EGFR mutation
* 2\. Patients who have not received chemotherapy before. However, patients who received postoperative adjuvant chemotherapy more than 6 months ago are eligible.
* 3\. Patients with a lesion that can be measured a response-evaluation according to the RECIST criteria (at least one evaluable lesion)
* 4\. Patients aged 20 years or older
* 5\. ECOG performance status score of 0, 1 or 2
* 6\. Expected lifetime of ≥3 months
* 7\. Adequate bone marrow and liver functions maintained
1. Neutrophil count: \> 1,500/㎕
2. Platelet count: \> 100,000/㎕
3. Hb: \> 9.0g/dL
4. AST/ALT: \< 2.0 x upper normal limit
5. Bilirubin: \< 1.25 x upper normal limit
* 8\. Patients or their legally acceptable representatives must complete a written consent before initiation of the study and patients can comply with requirements for the study
Exclusion Criteria:
* 1\. Symptomatic central nervous system (CNS) malignant tumour or metastasis. However, the patients who are treated for CNS metastasis can be enrolled if their disease is radiologically stable and asymptomatic. Asymptomatic patients without a history of CNS metastasis do not need screening.
* 2\. Evidence of severe or uncontrolled systemic diseases at the investigator's discretion (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal diseases)
* 3\. Patients who have been treated with EGFR inhibitors before
* 4\. Patients treated with other investigational products or unapproved drugs within 28 days before enrollment in this study
* 5\. Pregnant and lactating women, and patients of childbearing who do not agree to use contraception
* 6\. Patients ineligible for the study at the investigator's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02146118
Study Brief:
Protocol Section:
NCT02146118