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

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).