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
Public ClinicalTrials.gov record NCT01345682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01345682
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 483 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 5, 2012 (Actual)
- Primary completion
- Mar 15, 2014 (Actual)
- Completion
- Dec 6, 2016 (Actual)
- Last update posted
- Feb 15, 2018
2012 – 2016
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1200.43.00113 Boehringer Ingelheim Investigational Site | Harvey | Illinois | — | — |
| 1200.43.00106 Boehringer Ingelheim Investigational Site | Peoria | Illinois | — | — |
| 1200.43.00110 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | — | — |
| 1200.43.00107 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1200.43.00105 Boehringer Ingelheim Investigational Site | Stony Brook | New York | — | — |
| 1200.43.00102 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1200.43.00103 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1200.43.00109 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01345682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 15, 2018 · Synced Nov 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01345682 live on ClinicalTrials.gov.