A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

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