NCT01856478

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Methotrexate	intravenous bolus injection once weekly
DRUG	Afatinib	oral intake of one film-coated tablet once daily

Timeline

• Start date: 2013-06-07
• Primary completion: 2018-08-22
• Completion: 2024-10-02
• First posted: 2013-05-17
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

53 sites across 8 countries: China, Egypt, Hong Kong, India, Philippines, South Korea, Taiwan, Thailand