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:
NCT01557959
Eligibility Criteria:
Inclusion Criteria:
* Histologic Documentation: Either histologic or cytologic documentation of non-small cell carcinoma (NSCLC) is necessary, and the following diagnostic categories are acceptable: squamous carcinoma, basaloid carcinoma, adenocarcinoma, bronchioloalveolar carcinoma, adenosquamous carcinoma, large cell carcinoma (not neuroendocrine), sarcomatoid carcinoma, and non-small cell carcinoma not otherwise specified (NOS); histologic or cytologic documentation of recurrence is required in patients who were previously completely resected
* Advanced Disease: Stage IIIB because of malignant pleural or pericardial effusion or stage IV disease
* Patients must be ineligible for Avastin or decline treatment with Avastin
* Prior Treatment: No prior chemotherapy or treatment with an EGFR inhibitor is allowed; brain metastasis must be under control (patient neurologically stable)
* All Patients must have Measurable or Non-Measurable Disease: measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension; the longest diameter of measurable lesions must be \>= 20 mm with conventional techniques or \>= 10 mm with spiral computed tomography (CT) scan; non-measurable disease includes the following:
* Bone lesions
* Brain metastasis or leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Tumor lesions situated in a previously irradiated area
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Granulocytes \>= 1,500/ul
* Platelets \>= 100,000/ul
* Creatinine =\< upper limit of normal (ULN)
* Bilirubin =\< 1.5 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 1.5 x ULN
* Alkaline (Alk.) phosphatase (phos.) =\< 2.5 x ULN
* Patients must provide verbal and written informed consent to participate in the study
Exclusion Criteria:
* Patients who are pregnant or nursing because of significant risk to the fetus/infant
* Patients with neuropathy \>= grade 2
* Patients with a psychiatric illness which would prevent the patient from giving informed consent
* Patients who are unable to take oral medications
* Women with child-bearing potential or men who are sexual partners of women with child-bearing potential who are not willing to practice adequate contraceptive measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01557959
Study Brief:
Protocol Section:
NCT01557959