LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Inclusion criteria: * Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy. * Documented progressive disease based on investigator assessment according to RECIST, following receipt of a cisplatin and/or carboplatin and/or Nedaplatin based regimen administered for recurrent and/or metastatic disease independent of whether patient progressed during or after platinum based therapy. * Measurable disease according to RECIST (version 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Visit 2. * Male and female patients age is 18 years or older * Signed and dated written informed consent that is in compliance with ICH-GCP and local law. Exclusion criteria: * Progressive disease within three months after completion of curatively intended treatment for locoregionally advanced or for metastatic head and neck squamous cell cancer (HNSCC). * Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary glands. * Any other than one previous platinum based systemic regimen given for recurrent and/or metastatic disease, with the exception of immunotherapy used either before or after platinum based treatment. Re-challenge with the platinum based regimen after a temporary break is considered an additional line regimen only in case of progression within the break. * Prior treatment with EGFR-tar…