This site uses cookies to improve your browsing experience. By using this site, you agree to their use. Cookie Information

LUX-Head & Neck 3 clinical trial

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 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 IV once weekly


Primary outcome measure:

  • 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.


Did you find this information useful?


1 (Accessed: July 2017).

*Afatinib is approved in more than 80 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information. Afatinib is being investigated in urothelial carcinoma (UC) and head and neck squamous cell carcinoma (HNSCC) and is not approved for these uses. The efficacy and safety of afatinib in UC and HNSCC have not been established.