LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Inclusion criteria:

1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx,
hypopharynx or larynx, not amenable for salvage surgery or radiotherapy

2. Documented progressive disease based on investigator assessment according to Response
Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles
of cisplatin or carboplatin administered for R/M disease

3. Measurable disease according to RECIST

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Progressive disease within three months of completion of curatively intended treatment
for locoregionally advanced or metastatic HNSCC

2. Any other than one previous platinum based systemic regimen given for R/M disease

3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules

4. Pregnancy or breast feeding