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LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

NCT01856478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-01-12

Study results available
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Summary

This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Methotrexate

intravenous bolus injection once weekly

DRUG

Afatinib

oral intake of one film-coated tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-07
Primary Completion
2018-08-22
Completion
2024-10-02

Countries

  • China
  • Egypt
  • Hong Kong
  • India
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856478 on ClinicalTrials.gov