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

A randomised, open-label, Phase III study to evaluate the efficacy and safety of oral afatinib vs intravenous (IV) methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma whose disease has progressed after platinum-based therapy.

Trial CTgov-Identifier: NCT01856478


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- and/or nedaplatin-based regimen
Eastern Cooperative Oncology Group performance status 0–1

N = 330 (estimated)

Randomisation 2:1

  • Afatinib 40 mg
    Oral once daily

  • Methotrexate 40 mg/m2
    Intravenous once weekly


Primary outcome measures:
Progression-free survival

Secondary outcome measures:
Overall survival
Objective response
Health-related quality of life

Trial Status:

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: April 2017).