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

Completed · Phase 3

Conditions studied: Head and Neck Neoplasms, Carcinoma, Squamous Cell

In brief

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

Key facts

Study ID

NCT01345682

Run by

Boehringer Ingelheim

People needed

483

Starts

2012-01-05

Expected to finish

2016-12-06

Last updated by the study team

2018-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
• Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
• Measurable disease according to RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if…

• Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
• Any other than one previous platinum based systemic regimen given for R/M disease
• Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
• Pregnancy or breast feeding

Where it is running

• 1200.43.00106 Boehringer Ingelheim Investigational Site — Peoria, Illinois, United States
• 1200.43.00110 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 1200.43.00107 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1200.43.00105 Boehringer Ingelheim Investigational Site — Stony Brook, New York, United States
• 1200.43.00102 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1200.43.00103 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1200.43.00109 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1200.43.05401 Boehringer Ingelheim Investigational Site — Ciudad Autonoma de Bs As, Argentina
• 1200.43.05402 Boehringer Ingelheim Investigational Site — Santa Fe, Argentina
• 1200.43.05403 Boehringer Ingelheim Investigational Site — Villa Domínico, Argentina
• 1200.43.04303 Boehringer Ingelheim Investigational Site — Leoben, Austria
• 1200.43.04305 Boehringer Ingelheim Investigational Site — Salzburg, Austria
• 1200.43.04301 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1200.43.03202 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1200.43.03203 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 1200.43.03204 Boehringer Ingelheim Investigational Site — Ghent, Belgium
• 1200.43.03201 Boehringer Ingelheim Investigational Site — Leuven, Belgium
• 1200.43.05504 Boehringer Ingelheim Investigational Site — Barretos, Brazil
• 1200.43.05505 Boehringer Ingelheim Investigational Site — Jaú, Brazil
• 1200.43.05507 Boehringer Ingelheim Investigational Site — Passo Fundo, Brazil
• 1200.43.05503 Boehringer Ingelheim Investigational Site — Porto Alegre, Brazil
• 1200.43.05502 Boehringer Ingelheim Investigational Site — Rio de Janeiro, Brazil
• 1200.43.05501 Boehringer Ingelheim Investigational Site — São Paulo, Brazil
• 1200.43.05506 Boehringer Ingelheim Investigational Site — São Paulo, Brazil
• 1200.43.00113 Boehringer Ingelheim Investigational Site — Harvey, Illinois, United States

Full record on ClinicalTrials.gov

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