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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT01799161
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed NSCLC (squamous, adeno-, large cell anaplastic, bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural effusion, stage IV, or recurrent disease.
* At least one site of measurable disease.
* Brain metastasis if present and treated must be stable by CT scan or MRI for at least 4 weeks after treatment.
* Patient must have received and failed at least one line of palliative therapy (chemotherapy or biological therapy)
* Age \>= 18 years.
* ECOG performance status 0-2.
* Life expectancy \>= 3 months.
* Laboratory parameters
* Hemoglobin levels \>= 10.0 (transfusions allowed if necessary).
* ANC \>= 1,500.
* Platelets \>= 100k.
* Creatinine clearance \>= 50 ml/min.
* Total and direct bilirubin: \< 3.0 x upper institution limit for normal.
* Liver function tests: AST, ALT, and AlkP \< 3.0 x upper institution limit for normal.
* Signed informed consent.
Exclusion Criteria:
* Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. Patients with history of these conditions who are stable taking cardiac medications will also be excluded.
* Pregnant or lactating women (negative test for pregnancy is required of women of childbearing potential).
* Known HIV infection.
* Uncontrolled or untreated brain or spinal cord metastases.
* Active infection.
* Concomitant steroid or other immunosuppressive therapy.
* Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
* Meningeal carcinomatosis.
* Chemotherapy, radiation therapy, or other anti-tumor therapy during the last three weeks.
* Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic lupus erythematousus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, glomerulonephritis.
* Compromised lung function:
* FeV1 \< 30% of the predicted value, or
* DLCO \< 30% of the predicted value, or
* PCO2 \> 45 mmHg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01799161
Study Brief:
Protocol Section:
NCT01799161