NCT01345682

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) 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: 483 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Conditions

• Head and Neck Neoplasms
• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	Afatinib	Once daily
DRUG	Methotrexate	Weekly

Timeline

• Start date: 2012-01-05
• Primary completion: 2014-03-15
• Completion: 2016-12-06
• First posted: 2011-05-02
• Last updated: 2018-02-15
• Results posted: 2015-04-14

Locations

101 sites across 19 countries: United States, Argentina, Austria, Belgium, Brazil, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Russia, South Africa, Spain, Sweden, Switzerland