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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01345682

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.

ClinicalTrials.gov public records Last synced May 7, 2026, 9:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. 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

Study identification

NCT ID
NCT01345682
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
483 participants

Conditions and interventions

Interventions

  • Afatinib Drug
  • Methotrexate Drug

Drug

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 4, 2012
Primary completion
Mar 14, 2014
Completion
Dec 5, 2016
Last update posted
Feb 14, 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 14, 2018 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01345682 live on ClinicalTrials.gov.

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