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

• Changes in safety laboratory parameters (Haemoglobin, Leukocytes, Neutrophils, Lymphocytes, Platelets, Potassium, Creatinine, AST, ALT, Bilirubin, Alkaline phosphatase, Proteinuria) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
• DFS rate at 2 years [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Overall Survival (OS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

• Changes in safety laboratory parameters [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
• DFS rate at 2 years [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Overall Survival (OS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
• Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

• Drug: Placebo
  Once daily
• Drug: Afatinib
  Once daily

• Experimental: Afatinib (BIBW 2992)
  Once daily
  Intervention: Drug: Afatinib
• Placebo Comparator: Placebo
  Once daily
  Intervention: Drug: Placebo

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