LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Inclusion criteria:

• Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
• Unresected tumour prior to chemo-radiotherapy (CRT)
• Concomitant CRT completed prior to randomisation
• After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
• Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

• Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
• Cancer of nasopharynx, sinuses, and/or salivary glands
• Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
• Known pre-existing Interstitial Lung Disease (ILD)
• Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months