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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00544960
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
* All patients must have measurable disease.
* No unstable or progressive brain metastases.
* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
* ECOG performance status 0-1
* Adequate hematologic function
* Adequate liver and renal function
* Ability to swallow oral medication
Exclusion Criteria:
* Prior chemotherapy regimen containing docetaxel.
* Active secondary malignancy.
* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00544960
Study Brief:
Protocol Section:
NCT00544960