Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

Inclusion Criteria:

• Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.
• Treatment plan includes a platinum-based doublet chemotherapy.
• ECOG 0, 1 or 2.
• Self-reported loss of body weight or anorexia.
• Serum C-reactive protein ≥5 mg/L.
• Life expectancy of at least 6 months.
• Adequate bone marrow, liver and renal function.
• Normal serum potassium.
• Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

• Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.
• Concomitant therapy with an appetite stimulant.
• History of poorly controlled hypertension or congestive heart failure.
• Any implanted devices that could interfere with DXA scanning.
• Prolongation of QT interval.
• History of additional risk factors for torsades de pointe.
• Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.
• Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.
• Any second malignancy which might confound the interpretation of safety or efficacy assessments.
• Any condition which increases the patient's risk for participating in the study.