Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

Exclusion Criteria

• •1. Any of the following laboratory abnormalities:
• •1. Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
• •2. Platelet count \<100,000 cells/mm3 (100 x 109/L)
• •3. Serum creatinine \>1.5 mg/dL (133 mmol/L)
• •4. Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
• •5. Serum total bilirubin \>or = 1.5 mg/dL (26 mmol/L)
• •2. Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
• •3. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year.
• •4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
• •5. More than one prior chemotherapy for advanced NSCLC.
• •6. Concurrent use of any other anti-cancer agents.
• •7. Any prior use of lenalidomide.
• •8. Pregnant or lactating females.
• •9. Prior \> or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
• •10. Prior \> or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
• •11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
• •12. Known Hepatitis C.