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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00749567
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
* Progression to first-line therapy for advanced/metastatic NSCLC
* Bi-dimensionally measurable disease (not included in radiation field)
* ECOG performance status of 0-2
* Life expectancy of more than 6 months
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine \<1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* Signed informed consent
Exclusion Criteria:
* Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
* Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
* Surgery or radiation therapy within the last 14 days from study entry
* Active infection
* History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
* Patients on other experimental treatment protocols
* History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00749567
Study Brief:
Protocol Section:
NCT00749567