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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT01066195
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
4. Never smoker (less than 100 cigarette for the life time)
5. 18 year or older
6. ECOG 0-2
7. No history of biologic or immunotherapy
8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)
Exclusion Criteria:
1. symptomatic brain metastasis
2. previously treated with EGFR tyrosine kinase inhibitor
3. previously treated with antifolate agents
4. poor oral absorption
5. patients with active infection
6. uncontrolled diabetes mellitus
7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
8. pregnant or nursing patients
9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01066195
Study Brief:
Protocol Section:
NCT01066195