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

• Changes in safety laboratory parameters (Haemoglobin, Leukocytes, Neutrophils, Lymphocytes, Platelets, Potassium, Creatinine, AST, ALT, Bilirubin, Alkaline phosphatase, Proteinuria) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
• Overall survival (OS) is the key secondary endpoint [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Objective response based on RECIST [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Health related quality of life (HRQOL) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Incidence and intensity of adverse events [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]

• Changes in safety laboratory parameters [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
• Overall survival (OS) is the key secondary endpoint [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Objective response based on RECIST [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Health related quality of life (HRQOL) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
• Incidence and intensity of adverse events [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

• Head and Neck Neoplasms
• Carcinoma, Squamous Cell

• Drug: Afatinib
  Once daily
• Drug: Methotrexate
  Weekly

• Experimental: Afatinib (BIBW 2992)
  Once daily
  Intervention: Drug: Afatinib
• Active Comparator: Methotrexate
  Weekly
  Intervention: Drug: Methotrexate

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