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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

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ClinicalTrials.gov Identifier: NCT01345669
Recruitment Status : Terminated
First Posted : May 2, 2011
Results First Posted : October 23, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Placebo Drug: Afatinib Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 17, 2011
Primary Completion Date : September 12, 2016
Study Completion Date : September 12, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Afatinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Afatinib (BIBW 2992)
Once daily
Drug: Afatinib
Once daily
Placebo Comparator: Placebo
Once daily
Drug: Placebo
Once daily


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345669


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01345669     History of Changes
Other Study ID Numbers: 1200.131
2011-000392-14 ( EudraCT Number: EudraCT )
First Posted: May 2, 2011    Key Record Dates
Results First Posted: October 23, 2017
Last Update Posted: December 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms