LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

November 3, 2017 updated by: Boehringer Ingelheim

A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Bs As, Argentina
        • 1200.131.05451 Boehringer Ingelheim Investigational Site
      • Cordoba, Argentina
        • 1200.131.05457 Boehringer Ingelheim Investigational Site
      • San Miguel de Tucuman, Argentina
        • 1200.131.05458 Boehringer Ingelheim Investigational Site
      • Santa Fe, Argentina
        • 1200.131.05452 Boehringer Ingelheim Investigational Site
      • Villa Dominico, Argentina
        • 1200.131.05453 Boehringer Ingelheim Investigational Site
  • Australia
    • Queensland
      • Wooloongabba, Queensland, Australia
        • 1200.131.06151 Boehringer Ingelheim Investigational Site
  • Austria
      • Leoben, Austria
        • 1200.131.04353 Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • 1200.131.04357 Boehringer Ingelheim Investigational Site
      • Salzburg, Austria
        • 1200.131.04355 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1200.131.04351 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1200.131.04359 Boehringer Ingelheim Investigational Site
  • Belgium
      • Brussel, Belgium
        • 1200.131.03259 Boehringer Ingelheim Investigational Site
      • Charleroi, Belgium
        • 1200.131.03256 Boehringer Ingelheim Investigational Site
      • Hasselt, Belgium
        • 1200.131.03255 Boehringer Ingelheim Investigational Site
      • Kortrijk, Belgium
        • 1200.131.03253 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1200.131.03252 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1200.131.03254 Boehringer Ingelheim Investigational Site
      • Namur, Belgium
        • 1200.131.03258 Boehringer Ingelheim Investigational Site
  • Brazil
      • Barretos, Brazil
        • 1200.131.05554 Boehringer Ingelheim Investigational Site
      • Jau, Brazil
        • 1200.131.05555 Boehringer Ingelheim Investigational Site
      • Passo Fundo, Brazil
        • 1200.131.05557 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1200.131.05553 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1200.131.05551 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1200.131.05556 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1200.131.00152 Boehringer Ingelheim Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • 1200.131.00157 Boehringer Ingelheim Investigational Site
      • Windsor, Ontario, Canada
        • 1200.131.00151 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1200.131.00153 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1200.131.00154 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1200.131.00155 Boehringer Ingelheim Investigational Site
  • Chile
      • Vina De Mar, Chile
        • 1200.131.05652 Boehringer Ingelheim Investigational Site
      • Vina del Mar, Chile
        • 1200.131.05651 Boehringer Ingelheim Investigational Site
  • Czechia
      • Brno, Czechia
        • 1200.131.04254 Boehringer Ingelheim Investigational Site
      • Praha 5, Czechia
        • 1200.131.04253 Boehringer Ingelheim Investigational Site
      • Praha 8, Czechia
        • 1200.131.04251 Boehringer Ingelheim Investigational Site
  • Denmark
      • København Ø, Denmark
        • 1200.131.04551 Boehringer Ingelheim Investigational Site
  • Egypt
      • Alexandria, Egypt
        • 1200.131.2052 Boehringer Ingelheim Investigational Site
  • Finland
      • Turku, Finland
        • 1200.131.35851 Boehringer Ingelheim Investigational Site
  • France
      • Le Havre, France
        • 1200.131.03353 Boehringer Ingelheim Investigational Site
      • Marseille Cedex 5, France
        • 1200.131.03362 Boehringer Ingelheim Investigational Site
      • Nice cedex 2, France
        • 1200.131.03359 Boehringer Ingelheim Investigational Site
      • Orléans Cedex 2, France
        • 1200.131.03365 Boehringer Ingelheim Investigational Site
      • Pierre-Bénite, France
        • 1200.131.03355 Boehringer Ingelheim Investigational Site
      • Rouen, France
        • 1200.131.03367 Boehringer Ingelheim Investigational Site
      • Saint Cloud, France
        • 1200.131.03370 Boehringer Ingelheim Investigational Site
      • Saint Herblain Cedex, France
        • 1200.131.03354 Boehringer Ingelheim Investigational Site
      • Saint Priest en Jarez, France
        • 1200.131.03369 Boehringer Ingelheim Investigational Site
      • Salouel, France
        • 1200.131.03366 Boehringer Ingelheim Investigational Site
      • Tours, France
        • 1200.131.03356 Boehringer Ingelheim Investigational Site
      • Villejuif Cedex, France
        • 1200.131.03357 Boehringer Ingelheim Investigational Site
  • Germany
      • Essen, Germany
        • 1200.131.04954 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1200.131.04961 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1200.131.04953 Boehringer Ingelheim Investigational Site
      • Jena, Germany
        • 1200.131.04956 Boehringer Ingelheim Investigational Site
      • Kaiserslautern, Germany
        • 1200.131.04959 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1200.131.04951 Boehringer Ingelheim Investigational Site
      • Rostock, Germany
        • 1200.131.04957 Boehringer Ingelheim Investigational Site
      • Trier, Germany
        • 1200.131.04964 Boehringer Ingelheim Investigational Site
      • Ulm, Germany
        • 1200.131.04963 Boehringer Ingelheim Investigational Site
      • Villingen-Schwenningen, Germany
        • 1200.131.04962 Boehringer Ingelheim Investigational Site
  • Greece
      • Chaidari, Greece
        • 1200.131.03054 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 1200.131.03052 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1200.131.03651 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1200.131.03652 Boehringer Ingelheim Investigational Site
      • Budpest, Hungary
        • 1200.131.03656 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1200.131.03654 Boehringer Ingelheim Investigational Site
      • Kecskemet, Hungary
        • 1200.131.03655 Boehringer Ingelheim Investigational Site
  • India
      • Ahmadabad, India
        • 1200.131.09178 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1200.131.09165 Boehringer Ingelheim Investigational Site
      • Bikaner, India
        • 1200.131.09152 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1200.131.09163 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1200.131.09173 Boehringer Ingelheim Investigational Site
      • Delhi, India
        • 1200.131.09179 Boehringer Ingelheim Investigational Site
      • Gurgaon, India
        • 1200.131.09170 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1200.131.09180 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1200.131.09172 Boehringer Ingelheim Investigational Site
      • Karamsad,Anand, Gujarat, India
        • 1200.131.09176 Boehringer Ingelheim Investigational Site
      • Madurai, Tamil Nadu, India
        • 1200.131.09162 Boehringer Ingelheim Investigational Site
      • Mazagaon, Mumbai, India
        • 1200.131.09175 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1200.131.09151 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1200.131.09164 Boehringer Ingelheim Investigational Site
      • Vishakapatnam, India
        • 1200.131.09159 Boehringer Ingelheim Investigational Site
  • Israel
      • Haifa, Israel
        • 1200.131.97251 Boehringer Ingelheim Investigational Site
      • Petach Tikva, Israel
        • 1200.131.97253 Boehringer Ingelheim Investigational Site
  • Italy
      • Confreria (CN), Italy
        • 1200.131.03957 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1200.131.03951 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1200.131.03955 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1200.131.03960 Boehringer Ingelheim Investigational Site
  • Japan
      • Aichi, Nagoya, Japan
        • 1200.131.08156 Boehringer Ingelheim Investigational Site
      • Chiba, Kashiwa, Japan
        • 1200.131.08153 Boehringer Ingelheim Investigational Site
      • Hokkaido, Sapporo, Japan
        • 1200.131.08151 Boehringer Ingelheim Investigational Site
      • Hyogo, Akashi, Japan
        • 1200.131.08161 Boehringer Ingelheim Investigational Site
      • Hyogo, Kobe, Japan
        • 1200.131.08157 Boehringer Ingelheim Investigational Site
      • Kanagawa, Isehara, Japan
        • 1200.131.08159 Boehringer Ingelheim Investigational Site
      • Miyagi, Natori, Japan
        • 1200.131.08164 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1200.131.08160 Boehringer Ingelheim Investigational Site
      • Shizuoka, Sunto-gun, Japan
        • 1200.131.08155 Boehringer Ingelheim Investigational Site
      • Tochigi, Shimotsuke, Japan
        • 1200.131.08152 Boehringer Ingelheim Investigational Site
      • Tokyo, Koto-ku, Japan
        • 1200.131.08163 Boehringer Ingelheim Investigational Site
      • Tokyo, Meguro-ku, Japan
        • 1200.131.08154 Boehringer Ingelheim Investigational Site
  • Mexico
      • Mexico, Mexico
        • 1200.131.05252 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1200.131.03152 Boehringer Ingelheim Investigational Site
      • Leiden, Netherlands
        • 1200.131.03153 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1200.131.03151 Boehringer Ingelheim Investigational Site
  • Portugal
      • Almada, Portugal
        • 1200.131.35155 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1200.131.35154 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1200.131.35153 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 1200.131.35151 Boehringer Ingelheim Investigational Site
      • Évora, Portugal
        • 1200.131.35152 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1200.131.00759 Boehringer Ingelheim Investigational Site
      • Omsk, Russian Federation
        • 1200.131.00753 Boehringer Ingelheim Investigational Site
      • Pyatigorsk, Russian Federation
        • 1200.131.00760 Boehringer Ingelheim Investigational Site
      • Pyatigorsk, Russian Federation
        • 1200.131.00761 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1200.131.00763 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1200.131.00755 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1200.131.00762 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1200.131.03451 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1200.131.03454 Boehringer Ingelheim Investigational Site
      • Girona, Spain
        • 1200.131.03463 Boehringer Ingelheim Investigational Site
      • Hospitalet de Llobregat, Spain
        • 1200.131.03452 Boehringer Ingelheim Investigational Site
      • Lugo, Spain
        • 1200.131.03459 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.131.03457 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.131.03464 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.131.03465 Boehringer Ingelheim Investigational Site
      • Málaga, Spain
        • 1200.131.03456 Boehringer Ingelheim Investigational Site
      • Málaga, Spain
        • 1200.131.03462 Boehringer Ingelheim Investigational Site
      • Pamplona, Spain
        • 1200.131.03455 Boehringer Ingelheim Investigational Site
      • Pozuelo De Alarcón, Madrid, Spain
        • 1200.131.03460 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1200.131.03466 Boehringer Ingelheim Investigational Site
      • Zaragoza, Spain
        • 1200.131.03458 Boehringer Ingelheim Investigational Site
      • Ávila, Spain
        • 1200.131.03461 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1200.131.04652 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1200.131.04651 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland
        • 1200.131.04151 Boehringer Ingelheim Investigational Site
      • Bern, Switzerland
        • 1200.131.04152 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • 1200.131.03854 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1200.131.03851 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Denbighshire, United Kingdom
        • 1200.131.04456 Boehringer Ingelheim Investigational Site
      • Edinburgh, United Kingdom
        • 1200.131.04455 Boehringer Ingelheim Investigational Site
      • Exeter, United Kingdom
        • 1200.131.04459 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1200.131.04460 Boehringer Ingelheim Investigational Site
      • Leicester, United Kingdom
        • 1200.131.04453 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1200.131.04451 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1200.131.04452 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 1200.131.04454 Boehringer Ingelheim Investigational Site
      • Sutton, United Kingdom
        • 1200.131.04458 Boehringer Ingelheim Investigational Site
      • Whitchurch, Cardiff, United Kingdom
        • 1200.131.04457 Boehringer Ingelheim Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • 1200.131.00171 Boehringer Ingelheim Investigational Site
    • California
      • Orange, California, United States
        • 1200.131.00181 Boehringer Ingelheim Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • 1200.131.00177 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States
        • 1200.131.00185 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1200.131.00173 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1200.131.00176 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1200.131.00182 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 1200.131.00175 Boehringer Ingelheim Investigational Site
    • New York
      • Stony Brook, New York, United States
        • 1200.131.00179 Boehringer Ingelheim Investigational Site
      • The Bronx, New York, United States
        • 1200.131.00188 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • 1200.131.10200 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1200.131.00172 Boehringer Ingelheim Investigational Site
    • Texas
      • San Antonio, Texas, United States
        • 1200.131.00184 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane Valley, Washington, United States
        • 1200.131.00198 Boehringer Ingelheim Investigational Site
      • Wenatchee, Washington, United States
        • 1200.131.00183 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
  2. Unresected tumour prior to chemo-radiotherapy (CRT)
  3. Concomitant CRT completed prior to randomisation
  4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
  3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
  4. Known pre-existing Interstitial Lung Disease (ILD)
  5. Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afatinib (BIBW 2992)
Once daily
Drug: Afatinib
Once daily
Placebo Comparator: Placebo
Once daily
Drug: Placebo
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: Up to 5 years
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS) Rate at 2 Years
Time Frame: Up to 2 years
Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.
Up to 2 years
Percentage of Patient Deaths (Overall Survival (OS))
Time Frame: Up to 5 years
Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.
Up to 5 years
Patients With Improved Health Related Quality of Life (HRQOL)
Time Frame: Up to 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.
Up to 5 years
Time to Deterioration in Health Related Quality of Life (HRQOL)
Time Frame: Up to 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.
Up to 5 years
Health Related Quality of Life (HRQOL) Scores Over Time
Time Frame: Baseline and 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.
Baseline and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2011

Primary Completion (Actual)

September 12, 2016

Study Completion (Actual)

September 12, 2016

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.131
  • 2011-000392-14 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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