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
- Registration Number
- NCT01345669
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 617
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afatinib (BIBW 2992) Afatinib Once daily Placebo Placebo Once daily
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) 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
Name Time Method Disease Free Survival (DFS) Rate at 2 Years 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.
Percentage of Patient Deaths (Overall Survival (OS)) 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.
Patients With Improved Health Related Quality of Life (HRQOL) 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.
Time to Deterioration in Health Related Quality of Life (HRQOL) 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.
Health Related Quality of Life (HRQOL) Scores Over Time 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.
Trial Locations
- Locations (162)
1200.131.05555 Boehringer Ingelheim Investigational Site
🇧🇷Jau, Brazil
1200.131.06151 Boehringer Ingelheim Investigational Site
🇦🇺Wooloongabba, Queensland, Australia
1200.131.05451 Boehringer Ingelheim Investigational Site
🇦🇷Ciudad Autonoma de Bs As, Argentina
1200.131.00198 Boehringer Ingelheim Investigational Site
🇺🇸Spokane Valley, Washington, United States
1200.131.05452 Boehringer Ingelheim Investigational Site
🇦🇷Santa Fe, Argentina
1200.131.05458 Boehringer Ingelheim Investigational Site
🇦🇷San Miguel de Tucuman, Argentina
1200.131.05457 Boehringer Ingelheim Investigational Site
🇦🇷Cordoba, Argentina
1200.131.05453 Boehringer Ingelheim Investigational Site
🇦🇷Villa Dominico, Argentina
1200.131.03356 Boehringer Ingelheim Investigational Site
🇫🇷Tours, France
1200.131.05553 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1200.131.04961 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
1200.131.05556 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1200.131.05554 Boehringer Ingelheim Investigational Site
🇧🇷Barretos, Brazil
1200.131.09178 Boehringer Ingelheim Investigational Site
🇮🇳Ahmadabad, India
1200.131.08163 Boehringer Ingelheim Investigational Site
🇯🇵Tokyo, Koto-ku, Japan
1200.131.97251 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1200.131.04254 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czechia
1200.131.03451 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1200.131.09162 Boehringer Ingelheim Investigational Site
🇮🇳Madurai, Tamil Nadu, India
1200.131.03466 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1200.131.08156 Boehringer Ingelheim Investigational Site
🇯🇵Aichi, Nagoya, Japan
1200.131.03153 Boehringer Ingelheim Investigational Site
🇳🇱Leiden, Netherlands
1200.131.03957 Boehringer Ingelheim Investigational Site
🇮🇹Confreria (CN), Italy
1200.131.03960 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1200.131.08161 Boehringer Ingelheim Investigational Site
🇯🇵Hyogo, Akashi, Japan
1200.131.08154 Boehringer Ingelheim Investigational Site
🇯🇵Tokyo, Meguro-ku, Japan
1200.131.09179 Boehringer Ingelheim Investigational Site
🇮🇳Delhi, India
1200.131.09180 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1200.131.03459 Boehringer Ingelheim Investigational Site
🇪🇸Lugo, Spain
1200.131.08157 Boehringer Ingelheim Investigational Site
🇯🇵Hyogo, Kobe, Japan
1200.131.35154 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1200.131.03463 Boehringer Ingelheim Investigational Site
🇪🇸Girona, Spain
1200.131.03955 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1200.131.03461 Boehringer Ingelheim Investigational Site
🇪🇸Ávila, Spain
1200.131.08152 Boehringer Ingelheim Investigational Site
🇯🇵Tochigi, Shimotsuke, Japan
1200.131.03465 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1200.131.08151 Boehringer Ingelheim Investigational Site
🇯🇵Hokkaido, Sapporo, Japan
1200.131.08159 Boehringer Ingelheim Investigational Site
🇯🇵Kanagawa, Isehara, Japan
1200.131.03454 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1200.131.00762 Boehringer Ingelheim Investigational Site
🇷🇺Ufa, Russian Federation
1200.131.04152 Boehringer Ingelheim Investigational Site
🇨🇭Bern, Switzerland
1200.131.03951 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1200.131.04456 Boehringer Ingelheim Investigational Site
🇬🇧Denbighshire, United Kingdom
1200.131.04460 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1200.131.04454 Boehringer Ingelheim Investigational Site
🇬🇧Sheffield, United Kingdom
1200.131.03457 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1200.131.08155 Boehringer Ingelheim Investigational Site
🇯🇵Shizuoka, Sunto-gun, Japan
1200.131.03452 Boehringer Ingelheim Investigational Site
🇪🇸Hospitalet de Llobregat, Spain
1200.131.04652 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1200.131.04452 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1200.131.03455 Boehringer Ingelheim Investigational Site
🇪🇸Pamplona, Spain
1200.131.03462 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1200.131.04455 Boehringer Ingelheim Investigational Site
🇬🇧Edinburgh, United Kingdom
1200.131.03851 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1200.131.04459 Boehringer Ingelheim Investigational Site
🇬🇧Exeter, United Kingdom
1200.131.04451 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1200.131.03456 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1200.131.00176 Boehringer Ingelheim Investigational Site
🇺🇸Boston, Massachusetts, United States
1200.131.00179 Boehringer Ingelheim Investigational Site
🇺🇸Stony Brook, New York, United States
1200.131.00172 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
1200.131.00184 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1200.131.00183 Boehringer Ingelheim Investigational Site
🇺🇸Wenatchee, Washington, United States
1200.131.00157 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1200.131.04551 Boehringer Ingelheim Investigational Site
🇩🇰København Ø, Denmark
1200.131.08160 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1200.131.04355 Boehringer Ingelheim Investigational Site
🇦🇹Salzburg, Austria
1200.131.05652 Boehringer Ingelheim Investigational Site
🇨🇱Vina De Mar, Chile
1200.131.00152 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1200.131.03252 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1200.131.04359 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1200.131.03256 Boehringer Ingelheim Investigational Site
🇧🇪Charleroi, Belgium
1200.131.03254 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1200.131.2052 Boehringer Ingelheim Investigational Site
🇪🇬Alexandria, Egypt
1200.131.03651 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1200.131.09173 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1200.131.00759 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1200.131.09176 Boehringer Ingelheim Investigational Site
🇮🇳Karamsad,Anand, Gujarat, India
1200.131.09159 Boehringer Ingelheim Investigational Site
🇮🇳Vishakapatnam, India
1200.131.09170 Boehringer Ingelheim Investigational Site
🇮🇳Gurgaon, India
1200.131.09175 Boehringer Ingelheim Investigational Site
🇮🇳Mazagaon, Mumbai, India
1200.131.35152 Boehringer Ingelheim Investigational Site
🇵🇹Évora, Portugal
1200.131.05252 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1200.131.00760 Boehringer Ingelheim Investigational Site
🇷🇺Pyatigorsk, Russian Federation
1200.131.35153 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1200.131.04151 Boehringer Ingelheim Investigational Site
🇨🇭Basel, Switzerland
1200.131.35151 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1200.131.00763 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1200.131.00755 Boehringer Ingelheim Investigational Site
🇷🇺Ufa, Russian Federation
1200.131.03854 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1200.131.00153 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1200.131.00154 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1200.131.03460 Boehringer Ingelheim Investigational Site
🇪🇸Pozuelo De Alarcón, Madrid, Spain
1200.131.00171 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
1200.131.00181 Boehringer Ingelheim Investigational Site
🇺🇸Orange, California, United States
1200.131.00185 Boehringer Ingelheim Investigational Site
🇺🇸New Haven, Connecticut, United States
1200.131.00177 Boehringer Ingelheim Investigational Site
🇺🇸Aurora, Colorado, United States
1200.131.00173 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1200.131.00182 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1200.131.00175 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
1200.131.00188 Boehringer Ingelheim Investigational Site
🇺🇸The Bronx, New York, United States
1200.131.10200 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1200.131.04353 Boehringer Ingelheim Investigational Site
🇦🇹Leoben, Austria
1200.131.04357 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1200.131.04351 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1200.131.03253 Boehringer Ingelheim Investigational Site
🇧🇪Kortrijk, Belgium
1200.131.03259 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1200.131.03255 Boehringer Ingelheim Investigational Site
🇧🇪Hasselt, Belgium
1200.131.03258 Boehringer Ingelheim Investigational Site
🇧🇪Namur, Belgium
1200.131.05557 Boehringer Ingelheim Investigational Site
🇧🇷Passo Fundo, Brazil
1200.131.00155 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1200.131.05551 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1200.131.05651 Boehringer Ingelheim Investigational Site
🇨🇱Vina del Mar, Chile
1200.131.04253 Boehringer Ingelheim Investigational Site
🇨🇿Praha 5, Czechia
1200.131.04251 Boehringer Ingelheim Investigational Site
🇨🇿Praha 8, Czechia
1200.131.35851 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1200.131.03362 Boehringer Ingelheim Investigational Site
🇫🇷Marseille Cedex 5, France
1200.131.03353 Boehringer Ingelheim Investigational Site
🇫🇷Le Havre, 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
1200.131.03357 Boehringer Ingelheim Investigational Site
🇫🇷Villejuif Cedex, France
1200.131.04954 Boehringer Ingelheim Investigational Site
🇩🇪Essen, 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
1200.131.04962 Boehringer Ingelheim Investigational Site
🇩🇪Villingen-Schwenningen, Germany
1200.131.04963 Boehringer Ingelheim Investigational Site
🇩🇪Ulm, Germany
1200.131.03054 Boehringer Ingelheim Investigational Site
🇬🇷Chaidari, Greece
1200.131.03052 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1200.131.03652 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1200.131.03655 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemet, Hungary
1200.131.03654 Boehringer Ingelheim Investigational Site
🇭🇺Debrecen, Hungary
1200.131.03656 Boehringer Ingelheim Investigational Site
🇭🇺Budpest, Hungary
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
1200.131.09172 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1200.131.09151 Boehringer Ingelheim Investigational Site
🇮🇳New Delhi, India
1200.131.09164 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1200.131.97253 Boehringer Ingelheim Investigational Site
🇮🇱Petach Tikva, Israel
1200.131.08153 Boehringer Ingelheim Investigational Site
🇯🇵Chiba, Kashiwa, Japan
1200.131.08164 Boehringer Ingelheim Investigational Site
🇯🇵Miyagi, Natori, Japan
1200.131.35155 Boehringer Ingelheim Investigational Site
🇵🇹Almada, Portugal
1200.131.03152 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1200.131.03151 Boehringer Ingelheim Investigational Site
🇳🇱Rotterdam, Netherlands
1200.131.00753 Boehringer Ingelheim Investigational Site
🇷🇺Omsk, Russian Federation
1200.131.00761 Boehringer Ingelheim Investigational Site
🇷🇺Pyatigorsk, Russian Federation
1200.131.03464 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1200.131.03458 Boehringer Ingelheim Investigational Site
🇪🇸Zaragoza, Spain
1200.131.04651 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1200.131.04453 Boehringer Ingelheim Investigational Site
🇬🇧Leicester, United Kingdom
1200.131.04457 Boehringer Ingelheim Investigational Site
🇬🇧Whitchurch, Cardiff, United Kingdom
1200.131.04458 Boehringer Ingelheim Investigational Site
🇬🇧Sutton, United Kingdom
1200.131.00151 Boehringer Ingelheim Investigational Site
🇨🇦Windsor, Ontario, Canada