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

Inclusion Criteria: 1. 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 2. Hemoglobin level at or below 120 g/L; and 3. At least 18 years of age; Exclusion Criteria: 1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months; 2. Patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence; 3. Planned high dose thoracic radiation therapy (\>10 fractions); 4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL; 5. Expected survival of three months or less; 6. ECOG Performance status of 3 or 4 (see Appendix D); 7. 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); 8. Blood transfusions within the last 14 days; 9. Previous use of erythropoietin; 10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding); 11. Evidence of untreated folate or vitamin B12 deficiency; 12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg; 13. History of seizure disorder; 14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug; 15. Pregnancy, lactation or parturition within the previous 30 days; 16. Unwillingness or inability to complete the required QoL questionnaires; 17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires; 18. Geographically inaccessible for treatment or follow-up evaluations; 19. Currently enrolled in an ongoing therapeutic study;