Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01345682•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
•2. 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
•3. Measurable disease according to RECIST
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

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

Locations (101)

1200.43.00113 Boehringer Ingelheim Investigational Site

Harvey, Illinois, United States

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

Key Dates

Start Date

January 5, 2012

Primary Completion Date

March 15, 2014

Completion Date

December 6, 2016

Last Updated

February 15, 2018

Enrollment

483

ACTUAL participants

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

Afatinib

DRUG

Methotrexate

DRUG

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT04099290

Head and Neck NeoplasmCarcinoma, Squamous Cell

View study

RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069

Head and Neck Neoplasms

View study

RECRUITINGPHASE1

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Study Project in the Geriatric Population

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial