Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Inclusion Criteria

• •Ability to understand and the willingness to sign a written informed consent form; the consent form must be signed by the patient prior to any study-specific procedures.
• •Patients age ≥ 18 years with histologically confirmed wet Stage IIIB (with malignant pleural effusion) or Stage IV non-small cell lung cancer (metastatic or recurrent).
• •Pathologic confirmation of non-small cell lung cancer at Memorial Sloan-Kettering Cancer Center.
• •Presence of exon 19 or exon 21 EGFR activating mutation.
• •No prior EGFR tyrosine kinase therapy.
• •No prior systemic therapy for advanced NSCLC (Stage IIIB with malignant effusion or Stage IV)
• •Karnofsky performance status \> or = to 70% OR ECOG performance status ≤ 2.
• •Measurable disease defined as greater than or equal to one known/suspected malignant lesion \> or = to 1 cm measurable in two dimensions.
• •Adequate hematologic, renal, and/or hepatic function: WBC \> or = to 3,000/ul, hemoglobin \> or = to 9.0 g/dl, platelet count \> or = to 100,000/ul, total bilirubin ≤ 1.5 X UNL, AST ≤ 2.5 X UNL, and serum creatinine within 1.5 x the upper limit of normal (\<1.95 at MSKCC) or calculated creatinine clearance \> or = to 60 ml/min.
• •Able to swallow and retain oral medication.
• •Willingness and ability to comply with study procedures and follow-up examination.
• •Four weeks since any major surgery, completion of radiation, or completion of all prior chemotherapy.
• •Acute toxicities of any prior therapy must have resolved to \< Grade 1 or baseline prior to starting study therapy.
• •Effective contraception.