Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)

Inclusion Criteria: Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and Hemoglobin level at or below 120 g/L; and At least 18 years of age; Exclusion Criteria: Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months; Patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence; Planned high dose thoracic radiation therapy (>10 fractions); A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL; Expected survival of three months or less; ECOG Performance status of 3 or 4 (see Appendix D); Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required); Blood transfusions within the last 14 days; Previous use of erythropoietin; Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding); Evidence of untreated folate or vitamin B12 deficiency; History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg; History of seizure disorder; Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug; Pregnancy, lactation or parturition within the previous 30 days; Unwillingness or inability to complete the required QoL questionnaires; Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires; Geographically inaccessible for treatment or follow-up evaluations; Currently enrolled in an ongoing therapeutic study;