A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

Inclusion Criteria:

signature of informed consent
Age >= 18
histologically or cytologically confirmed small cell lung cancer (SCLC)
extensive stage SCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
brain metastases that are asymptomatic and do not require steroid control
females of child bearing potential must use two forms of birth control

Exclusion Criteria:

pregnant or lactating females
prior use of cytotoxic chemotherapy
surgery within 14 days of study
radiation within 14 days of study
prior therapy with CC-4047 (pomalidomide), lenalidomide or thalidomide
concurrent use or anticipated use of anti-cancer agents
absolute neutrophil count (ANC) < 1500/mm^3
platelets < 100 x 10^3/µL
serum creatinine >2.5 mg/dL
serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
serum total bilirubin > 1.8 mg/dL
uncontrolled hypercalcemia
creatinine clearance <50 mL/min
uncontrolled hypertension
neuropathy >= grade 2
body mass index (BMI) >= 40
any other active invasive malignancy requiring treatment
known chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
inability or unwillingness to comply with birth control requirements