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
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention
Name: Placebo Type: Drug
Name: Afatinib Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
1200.131.00171 Boehringer Ingelheim Investigational Site
Little Rock, Alaska, United States
Status: Recruiting
1200.131.00181 Boehringer Ingelheim Investigational Site
Orange, California, United States
Status: Recruiting
1200.131.00177 Boehringer Ingelheim Investigational Site
Aurora, Colorado, United States
Status: Recruiting
1200.131.00185 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
Status: Recruiting
1200.131.00193 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Status: Recruiting
1200.131.00194 Boehringer Ingelheim Investigational Site
Athens, Georgia, United States
Status: Recruiting
1200.131.00191 Boehringer Ingelheim Investigational Site
Harvey, Illinois, United States
Status: Recruiting
1200.131.00173 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
Status: Terminated
1200.131.00176 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Status: Recruiting
1200.131.00190 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Status: Recruiting
1200.131.00195 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
Status: Recruiting
1200.131.00199 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
Status: Not yet recruiting
1200.131.00182 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
Status: Recruiting
1200.131.00175 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
Status: Recruiting
1200.131.00188 Boehringer Ingelheim Investigational Site
Bronx, New York, United States
Status: Recruiting
1200.131.00179 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
Status: Recruiting
1200.131.00172 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
Status: Recruiting
1200.131.00184 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
Status: Terminated
1200.131.00198 Boehringer Ingelheim Investigational Site
Spokane Valley, Washington, United States
Status: Recruiting
1200.131.00183 Boehringer Ingelheim Investigational Site
Wenatchee, Washington, United States
Status: Recruiting
1200.131.05451 Boehringer Ingelheim Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina
Status: Recruiting
1200.131.05457 Boehringer Ingelheim Investigational Site
Cordoba, Argentina
Status: Recruiting
1200.131.05458 Boehringer Ingelheim Investigational Site
San Miguel de Tucuman, Argentina
Status: Recruiting
1200.131.05452 Boehringer Ingelheim Investigational Site
Santa Fe, Argentina
Status: Recruiting
1200.131.05453 Boehringer Ingelheim Investigational Site
Villa Dominico, Argentina
Status: Recruiting
1200.131.6154 Boehringer Ingelheim Investigational Site
St Leonards, New South Wales, Australia
Status: Not yet recruiting
1200.131.06151 Boehringer Ingelheim Investigational Site
Wooloongabba, Queensland, Australia
Status: Recruiting
1200.131.04353 Boehringer Ingelheim Investigational Site
Leoben, Austria
Status: Recruiting
1200.131.04357 Boehringer Ingelheim Investigational Site
Linz, Austria
Status: Recruiting
1200.131.04355 Boehringer Ingelheim Investigational Site
Salzburg, Austria
Status: Recruiting
1200.131.04351 Boehringer Ingelheim Investigational Site
Wien, Austria
Status: Recruiting
1200.131.04359 Boehringer Ingelheim Investigational Site
Wien, Austria
Status: Recruiting
1200.131.03259 Boehringer Ingelheim Investigational Site
Brussel, Belgium
Status: Recruiting
1200.131.03256 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
Status: Recruiting
1200.131.03251 Boehringer Ingelheim Investigational Site
Edegem, Belgium
Status: Recruiting
1200.131.03255 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
Status: Recruiting
1200.131.03253 Boehringer Ingelheim Investigational Site
Kortrijk, Belgium
Status: Recruiting
1200.131.03252 Boehringer Ingelheim Investigational Site
Liège, Belgium
Status: Recruiting
1200.131.03254 Boehringer Ingelheim Investigational Site
Liège, Belgium
Status: Recruiting
1200.131.03258 Boehringer Ingelheim Investigational Site
Namur, Belgium
Status: Recruiting
1200.131.05554 Boehringer Ingelheim Investigational Site
Barretos, Brazil
Status: Recruiting
1200.131.05555 Boehringer Ingelheim Investigational Site
Jau, Brazil
Status: Recruiting
1200.131.05557 Boehringer Ingelheim Investigational Site
Passo Fundo, Brazil
Status: Recruiting
1200.131.05553 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
Status: Recruiting
1200.131.05551 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Status: Recruiting
1200.131.05556 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Status: Recruiting
1200.131.00152 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Status: Recruiting
1200.131.00157 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Status: Recruiting
1200.131.00151 Boehringer Ingelheim Investigational Site
Windsor, Ontario, Canada
Status: Recruiting
1200.131.00153 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Status: Recruiting
1200.131.00154 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Status: Terminated
1200.131.00155 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Status: Recruiting
1200.131.05652 Boehringer Ingelheim Investigational Site
Vina de Mar, Chile
Status: Recruiting
1200.131.05651 Boehringer Ingelheim Investigational Site
Vina del Mar, Chile
Status: Recruiting
1200.131.04254 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
Status: Recruiting
1200.131.04255 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czech Republic
Status: Recruiting
1200.131.04252 Boehringer Ingelheim Investigational Site
Olomouc, Czech Republic
Status: Recruiting
1200.131.04253 Boehringer Ingelheim Investigational Site
Praha 5, Czech Republic
Status: Recruiting
1200.131.04251 Boehringer Ingelheim Investigational Site
Praha 8, Czech Republic
Status: Recruiting
1200.131.04551 Boehringer Ingelheim Investigational Site
København Ø, Denmark
Status: Recruiting
1200.131.35853 Boehringer Ingelheim Investigational Site
Oulu, Finland
Status: Recruiting
1200.131.35851 Boehringer Ingelheim Investigational Site
Turku, Finland
Status: Recruiting
1200.131.03353 Boehringer Ingelheim Investigational Site
Le Havre, France
Status: Recruiting
1200.131.03362 Boehringer Ingelheim Investigational Site
Marseille Cedex 5, France
Status: Recruiting
1200.131.03359 Boehringer Ingelheim Investigational Site
Nice cedex 2, France
Status: Completed
1200.131.03365 Boehringer Ingelheim Investigational Site
Orléans Cedex 2, France
Status: Recruiting
1200.131.03355 Boehringer Ingelheim Investigational Site
Pierre-Bénite, France
Status: Recruiting
1200.131.03367 Boehringer Ingelheim Investigational Site
Rouen, France
Status: Recruiting
1200.131.03370 Boehringer Ingelheim Investigational Site
Saint Cloud, France
Status: Recruiting
1200.131.03354 Boehringer Ingelheim Investigational Site
Saint Herblain Cedex, France
Status: Recruiting
1200.131.03369 Boehringer Ingelheim Investigational Site
Saint Priest en Jarez, France
Status: Recruiting
1200.131.03366 Boehringer Ingelheim Investigational Site
Salouel, France
Status: Recruiting
1200.131.03356 Boehringer Ingelheim Investigational Site
Tours, France
Status: Recruiting
1200.131.03357 Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
Status: Recruiting
1200.131.04954 Boehringer Ingelheim Investigational Site
Essen, Germany
Status: Recruiting
1200.131.04961 Boehringer Ingelheim Investigational Site
Freiburg, Germany
Status: Recruiting
1200.131.04953 Boehringer Ingelheim Investigational Site
Hannover, Germany
Status: Recruiting
1200.131.04956 Boehringer Ingelheim Investigational Site
Jena, Germany
Status: Recruiting
1200.131.04959 Boehringer Ingelheim Investigational Site
Kaiserslautern, Germany
Status: Recruiting
1200.131.04951 Boehringer Ingelheim Investigational Site
Leipzig, Germany
Status: Recruiting
1200.131.04965 Boehringer Ingelheim Investigational Site
Mainz, Germany
Status: Not yet recruiting
1200.131.04957 Boehringer Ingelheim Investigational Site
Rostock, Germany
Status: Recruiting
1200.131.04964 Boehringer Ingelheim Investigational Site
Trier, Germany
Status: Recruiting
1200.131.04963 Boehringer Ingelheim Investigational Site
Ulm, Germany
Status: Recruiting
1200.131.04962 Boehringer Ingelheim Investigational Site
Villingen-Schwenningen, Germany
Status: Recruiting
1200.131.03054 Boehringer Ingelheim Investigational Site
Chaidari, Greece
Status: Recruiting
1200.131.03058 Boehringer Ingelheim Investigational Site
Thermi, Greece
Status: Recruiting
1200.131.03052 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Status: Recruiting
1200.131.03651 Boehringer Ingelheim Investigational Site
Budapest, Hungary
Status: Recruiting
1200.131.03652 Boehringer Ingelheim Investigational Site
Budapest, Hungary
Status: Recruiting
1200.131.03656 Boehringer Ingelheim Investigational Site
Budpest, Hungary
Status: Recruiting
1200.131.03654 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
Status: Recruiting
1200.131.03655 Boehringer Ingelheim Investigational Site
Kecskemet, Hungary
Status: Recruiting
1200.131.09165 Boehringer Ingelheim Investigational Site
Bangalore, India
Status: Recruiting
1200.131.09152 Boehringer Ingelheim Investigational Site
Bikaner, India
Status: Recruiting
1200.131.09163 Boehringer Ingelheim Investigational Site
Chennai, India
Status: Recruiting
1200.131.09173 Boehringer Ingelheim Investigational Site
Chennai, India
Status: Not yet recruiting
1200.131.09170 Boehringer Ingelheim Investigational Site
Gurgaon, India
Status: Recruiting
1200.131.09176 Boehringer Ingelheim Investigational Site
Karamsad,Anand, Gujarat, India
Status: Recruiting
1200.131.09162 Boehringer Ingelheim Investigational Site
Madurai, Tamil Nadu, India
Status: Recruiting
1200.131.09175 Boehringer Ingelheim Investigational Site
Mazagaon, Mumbai, India
Status: Not yet recruiting
1200.131.09154 Boehringer Ingelheim Investigational Site
Mumbai, India
Status: Recruiting
1200.131.09155 Boehringer Ingelheim Investigational Site
Mumbai, India
Status: Recruiting
1200.131.09151 Boehringer Ingelheim Investigational Site
New Delhi, India
Status: Recruiting
1200.131.09164 Boehringer Ingelheim Investigational Site
Pune, India
Status: Recruiting
1200.131.09167 Boehringer Ingelheim Investigational Site
Pune, India
Status: Recruiting
1200.131.09159 Boehringer Ingelheim Investigational Site
Vishakapatnam, India
Status: Recruiting
1200.131.97251 Boehringer Ingelheim Investigational Site
Haifa, Israel
Status: Recruiting
1200.131.97253 Boehringer Ingelheim Investigational Site
Petach Tikva, Israel
Status: Recruiting
1200.131.03957 Boehringer Ingelheim Investigational Site
Confreria (cn), Italy
Status: Recruiting
1200.131.03951 Boehringer Ingelheim Investigational Site
Milano, Italy
Status: Recruiting
1200.131.03955 Boehringer Ingelheim Investigational Site
Milano, Italy
Status: Recruiting
1200.131.03960 Boehringer Ingelheim Investigational Site
Milano, Italy
Status: Recruiting
1200.131.03961 Boehringer Ingelheim Investigational Site
Reggio Emilia, Italy
Status: Recruiting
1200.131.03958 Boehringer Ingelheim Investigational Site
Viterbo, Italy
Status: Recruiting
1200.131.08161 Boehringer Ingelheim Investigational Site
Akashi-city, Hyogo, Japan
Status: Active, not recruiting
1200.131.08159 Boehringer Ingelheim Investigational Site
Isehara Kanagawa, Japan
Status: Recruiting
1200.131.08153 Boehringer Ingelheim Investigational Site
Kashiwa City, Chiba, Japan
Status: Recruiting
1200.131.08157 Boehringer Ingelheim Investigational Site
Kobe-city,Hyogo, Japan
Status: Recruiting
1200.131.08163 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo, Japan
Status: Recruiting
1200.131.08154 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo, Japan
Status: Recruiting
1200.131.08156 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
Status: Recruiting
1200.131.08164 Boehringer Ingelheim Investigational Site
Natori, Miyagi, Japan
Status: Recruiting
1200.131.08160 Boehringer Ingelheim Investigational Site
Osaka-shi,Osaka-fu, Japan
Status: Active, not recruiting
1200.131.08151 Boehringer Ingelheim Investigational Site
Sapporo City, Hokkaido, Japan
Status: Recruiting
1200.131.08152 Boehringer Ingelheim Investigational Site
shimotsuke-shi,Tochigi, Japan
Status: Recruiting
1200.131.08155 Boehringer Ingelheim Investigational Site
Sunto-gun, Shizuoka, Japan
Status: Recruiting
1200.131.05252 Boehringer Ingelheim Investigational Site
Mexico, Mexico
Status: Recruiting
1200.131.05251 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
Status: Not yet recruiting
1200.131.03152 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
Status: Recruiting
1200.131.03153 Boehringer Ingelheim Investigational Site
Leiden, Netherlands
Status: Recruiting
1200.131.03151 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
Status: Recruiting
1200.131.04853 Boehringer Ingelheim Investigational Site
Olsztyn, Poland
Status: Recruiting
1200.131.04852 Boehringer Ingelheim Investigational Site
Poznan, Poland
Status: Recruiting
1200.131.04851 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Status: Recruiting
1200.131.35155 Boehringer Ingelheim Investigational Site
Almada, Portugal
Status: Recruiting
1200.131.35154 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
Status: Recruiting
1200.131.35153 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
Status: Recruiting
1200.131.35151 Boehringer Ingelheim Investigational Site
Porto, Portugal
Status: Recruiting
1200.131.35152 Boehringer Ingelheim Investigational Site
Évora, Portugal
Status: Recruiting
1200.131.00751 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Status: Recruiting
1200.131.00759 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Status: Recruiting
1200.131.00753 Boehringer Ingelheim Investigational Site
Omsk, Russian Federation
Status: Recruiting
1200.131.00760 Boehringer Ingelheim Investigational Site
Pyatigorsk, Russian Federation
Status: Recruiting
1200.131.00761 Boehringer Ingelheim Investigational Site
Pyatigorsk, Russian Federation
Status: Recruiting
1200.131.00763 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Status: Recruiting
1200.131.00755 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
Status: Recruiting
1200.131.00762 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
Status: Recruiting
1200.131.03451 Boehringer Ingelheim Investigational Site
Barcelona, Spain
Status: Recruiting
1200.131.03454 Boehringer Ingelheim Investigational Site
Barcelona, Spain
Status: Recruiting
1200.131.03463 Boehringer Ingelheim Investigational Site
Girona, Spain
Status: Recruiting
1200.131.03452 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain
Status: Recruiting
1200.131.03459 Boehringer Ingelheim Investigational Site
Lugo, Spain
Status: Recruiting
1200.131.03457 Boehringer Ingelheim Investigational Site
Madrid, Spain
Status: Recruiting
1200.131.03464 Boehringer Ingelheim Investigational Site
Madrid, Spain
Status: Recruiting
1200.131.03465 Boehringer Ingelheim Investigational Site
Madrid, Spain
Status: Recruiting
1200.131.03456 Boehringer Ingelheim Investigational Site
Málaga, Spain
Status: Recruiting
1200.131.03462 Boehringer Ingelheim Investigational Site
Málaga, Spain
Status: Recruiting
1200.131.03455 Boehringer Ingelheim Investigational Site
Pamplona, Spain
Status: Recruiting
1200.131.03460 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Madrid, Spain
Status: Recruiting
1200.131.03466 Boehringer Ingelheim Investigational Site
Sevilla, Spain
Status: Recruiting
1200.131.03458 Boehringer Ingelheim Investigational Site
Zaragoza, Spain
Status: Recruiting
1200.131.03461 Boehringer Ingelheim Investigational Site
Ávila, Spain
Status: Recruiting
1200.131.04652 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
Status: Recruiting
1200.131.04651 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Status: Recruiting
1200.131.04151 Boehringer Ingelheim Investigational Site
Basel, Switzerland
Status: Terminated
1200.131.04152 Boehringer Ingelheim Investigational Site
Bern, Switzerland
Status: Recruiting
1200.131.03854 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
Status: Recruiting
1200.131.04456 Boehringer Ingelheim Investigational Site
Denbighshire, United Kingdom
Status: Recruiting
1200.131.04455 Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
Status: Recruiting
1200.131.04459 Boehringer Ingelheim Investigational Site
Exeter, United Kingdom
Status: Recruiting
1200.131.04460 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
Status: Recruiting
1200.131.04453 Boehringer Ingelheim Investigational Site
Leicester, United Kingdom
Status: Recruiting
1200.131.04451 Boehringer Ingelheim Investigational Site
London, United Kingdom
Status: Recruiting
1200.131.04452 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Status: Recruiting
1200.131.04454 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
Status: Recruiting
1200.131.04458 Boehringer Ingelheim Investigational Site
Sutton, United Kingdom
Status: Recruiting
1200.131.04457 Boehringer Ingelheim Investigational Site
Whitchurch, Cardiff, United Kingdom
Status: Recruiting
Start Date
October 2011
Completion Date
May 2019
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page