EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN). * Recurrent and/or metastatic SCCHN, not suitable for local therapy. * At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0). * Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry. Exclusion Criteria: * Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry. * Nasopharyngeal carcinoma. * Medical history of diagnosed interstitial lung disease. * Known hypersensitivity against any of the components of the trial treatment. * Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed). * Relevant cardiovascular co-morbidities. * Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent. * Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.