A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim

This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Inclusion Criteria:

• Adults greater than or equal to (≥) 18 years of age
• Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
• Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Exclusion Criteria:

• Macroscopic residual disease after surgery
• Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies