LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Inclusion criteria:

1. Histologically or cytologically confirmed loco-regionally advanced head and neck
squamous cell carcinoma (HNSCC), stage III to IVb

2. Unresected tumour prior to chemo-radiotherapy (CRT)

3. Concomitant CRT completed prior to randomisation

4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and
radiographic examinations

5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules,
EGFR-targeted antibodies, and/or any investigational agents for HNSCC

2. 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

3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated
superficial basal cell skin cancer and surgically cured cervical cancer in situ)
unless free of disease for at least five years

4. Known pre-existing Interstitial Lung Disease (ILD)

5. Pregnancy or breast feeding