A randomised, open-label, Phase III study to evaluate the efficacy and safety of oral afatinib vs intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma whose disease has progressed after platinum-based therapy.
LUX-Head & Neck 3: Afatinib* vs Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma After Platinum Based Chemotherapy
Histologically/cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable to salvage surgery or radiotherapy
Documented progressive disease following a cisplatin and/or carboplatin-based regimen
Eastern Cooperative Oncology Group performance status 0–1
Afatinib 40 mg
Oral once daily
Methotrexate 40 mg/m2
Intravenous once weekly
Primary Outcome Measures:
Secondary Outcome Measures:
Health-related quality of life
LUX-Head & Neck 3, initiated in May 2013, is the equivalent of the LUX-Head & Neck 1 trial in Asian patients. This trial is currently recruiting participants; participating countries include China, Taiwan, Egypt, Hong Kong, India, Korea, Philippines and Thailand.
(Accessed: May 2016).