Clinical trial NCT01345669: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Disease Free Survival (DFS) Rate at 2 Years
timeFrame: Up to 2 years
measure: Percentage of Patient Deaths (Overall Survival (OS))
timeFrame: Up to 5 years
measure: Patients With Improved Health Related Quality of Life (HRQOL)
timeFrame: Up to 5 years
measure: Time to Deterioration in Health Related Quality of Life (HRQOL)
timeFrame: Up to 5 years
measure: Health Related Quality of Life (HRQOL) Scores Over Time
timeFrame: Baseline and 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: 1200.131.00171 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Orange
country: United States
facility: 1200.131.00181 Boehringer Ingelheim Investigational Site
state: California
city: Aurora
country: United States
facility: 1200.131.00177 Boehringer Ingelheim Investigational Site
state: Colorado
city: New Haven
country: United States
facility: 1200.131.00185 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Baltimore
country: United States
facility: 1200.131.00173 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 1200.131.00176 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: 1200.131.00182 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: 1200.131.00175 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Stony Brook
country: United States
facility: 1200.131.00179 Boehringer Ingelheim Investigational Site
state: New York
city: The Bronx
country: United States
facility: 1200.131.00188 Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: 1200.131.10200 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: 1200.131.00172 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: 1200.131.00184 Boehringer Ingelheim Investigational Site
state: Texas
city: Spokane Valley
country: United States
facility: 1200.131.00198 Boehringer Ingelheim Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: 1200.131.00183 Boehringer Ingelheim Investigational Site
state: Washington
city: Ciudad Autonoma de Bs As
country: Argentina
facility: 1200.131.05451 Boehringer Ingelheim Investigational Site
city: Cordoba
country: Argentina
facility: 1200.131.05457 Boehringer Ingelheim Investigational Site
city: San Miguel de Tucuman
country: Argentina
facility: 1200.131.05458 Boehringer Ingelheim Investigational Site
city: Santa Fe
country: Argentina
facility: 1200.131.05452 Boehringer Ingelheim Investigational Site
city: Villa Dominico
country: Argentina
facility: 1200.131.05453 Boehringer Ingelheim Investigational Site
city: Wooloongabba
country: Australia
facility: 1200.131.06151 Boehringer Ingelheim Investigational Site
state: Queensland
city: Leoben
country: Austria
facility: 1200.131.04353 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1200.131.04357 Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: 1200.131.04355 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1200.131.04351 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1200.131.04359 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1200.131.03259 Boehringer Ingelheim Investigational Site
city: Charleroi
country: Belgium
facility: 1200.131.03256 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 1200.131.03255 Boehringer Ingelheim Investigational Site
city: Kortrijk
country: Belgium
facility: 1200.131.03253 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1200.131.03252 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1200.131.03254 Boehringer Ingelheim Investigational Site
city: Namur
country: Belgium
facility: 1200.131.03258 Boehringer Ingelheim Investigational Site
city: Barretos
country: Brazil
facility: 1200.131.05554 Boehringer Ingelheim Investigational Site
city: Jau
country: Brazil
facility: 1200.131.05555 Boehringer Ingelheim Investigational Site
city: Passo Fundo
country: Brazil
facility: 1200.131.05557 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1200.131.05553 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1200.131.05551 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1200.131.05556 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 1200.131.00152 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: 1200.131.00157 Boehringer Ingelheim Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: 1200.131.00151 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1200.131.00153 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1200.131.00154 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1200.131.00155 Boehringer Ingelheim Investigational Site
state: Quebec
city: Vina De Mar
country: Chile
facility: 1200.131.05652 Boehringer Ingelheim Investigational Site
city: Vina del Mar
country: Chile
facility: 1200.131.05651 Boehringer Ingelheim Investigational Site
city: Brno
country: Czechia
facility: 1200.131.04254 Boehringer Ingelheim Investigational Site
city: Praha 5
country: Czechia
facility: 1200.131.04253 Boehringer Ingelheim Investigational Site
city: Praha 8
country: Czechia
facility: 1200.131.04251 Boehringer Ingelheim Investigational Site
city: København Ø
country: Denmark
facility: 1200.131.04551 Boehringer Ingelheim Investigational Site
city: Alexandria
country: Egypt
facility: 1200.131.2052 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1200.131.35851 Boehringer Ingelheim Investigational Site
city: Le Havre
country: France
facility: 1200.131.03353 Boehringer Ingelheim Investigational Site
city: Marseille Cedex 5
country: France
facility: 1200.131.03362 Boehringer Ingelheim Investigational Site
city: Nice cedex 2
country: France
facility: 1200.131.03359 Boehringer Ingelheim Investigational Site
city: Orléans Cedex 2
country: France
facility: 1200.131.03365 Boehringer Ingelheim Investigational Site
city: Pierre-Bénite
country: France
facility: 1200.131.03355 Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 1200.131.03367 Boehringer Ingelheim Investigational Site
city: Saint Cloud
country: France
facility: 1200.131.03370 Boehringer Ingelheim Investigational Site
city: Saint Herblain Cedex
country: France
facility: 1200.131.03354 Boehringer Ingelheim Investigational Site
city: Saint Priest en Jarez
country: France
facility: 1200.131.03369 Boehringer Ingelheim Investigational Site
city: Salouel
country: France
facility: 1200.131.03366 Boehringer Ingelheim Investigational Site
city: Tours
country: France
facility: 1200.131.03356 Boehringer Ingelheim Investigational Site
city: Villejuif Cedex
country: France
facility: 1200.131.03357 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1200.131.04954 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1200.131.04961 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1200.131.04953 Boehringer Ingelheim Investigational Site
city: Jena
country: Germany
facility: 1200.131.04956 Boehringer Ingelheim Investigational Site
city: Kaiserslautern
country: Germany
facility: 1200.131.04959 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1200.131.04951 Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: 1200.131.04957 Boehringer Ingelheim Investigational Site
city: Trier
country: Germany
facility: 1200.131.04964 Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: 1200.131.04963 Boehringer Ingelheim Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: 1200.131.04962 Boehringer Ingelheim Investigational Site
city: Chaidari
country: Greece
facility: 1200.131.03054 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1200.131.03052 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1200.131.03651 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1200.131.03652 Boehringer Ingelheim Investigational Site
city: Budpest
country: Hungary
facility: 1200.131.03656 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1200.131.03654 Boehringer Ingelheim Investigational Site
city: Kecskemet
country: Hungary
facility: 1200.131.03655 Boehringer Ingelheim Investigational Site
city: Ahmadabad
country: India
facility: 1200.131.09178 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1200.131.09165 Boehringer Ingelheim Investigational Site
city: Bikaner
country: India
facility: 1200.131.09152 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1200.131.09163 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1200.131.09173 Boehringer Ingelheim Investigational Site
city: Delhi
country: India
facility: 1200.131.09179 Boehringer Ingelheim Investigational Site
city: Gurgaon
country: India
facility: 1200.131.09170 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1200.131.09180 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1200.131.09172 Boehringer Ingelheim Investigational Site
city: Karamsad,Anand, Gujarat
country: India
facility: 1200.131.09176 Boehringer Ingelheim Investigational Site
city: Madurai, Tamil Nadu
country: India
facility: 1200.131.09162 Boehringer Ingelheim Investigational Site
city: Mazagaon, Mumbai
country: India
facility: 1200.131.09175 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1200.131.09151 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1200.131.09164 Boehringer Ingelheim Investigational Site
city: Vishakapatnam
country: India
facility: 1200.131.09159 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1200.131.97251 Boehringer Ingelheim Investigational Site
city: Petach Tikva
country: Israel
facility: 1200.131.97253 Boehringer Ingelheim Investigational Site
city: Confreria (CN)
country: Italy
facility: 1200.131.03957 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1200.131.03951 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1200.131.03955 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1200.131.03960 Boehringer Ingelheim Investigational Site
city: Aichi, Nagoya
country: Japan
facility: 1200.131.08156 Boehringer Ingelheim Investigational Site
city: Chiba, Kashiwa
country: Japan
facility: 1200.131.08153 Boehringer Ingelheim Investigational Site
city: Hokkaido, Sapporo
country: Japan
facility: 1200.131.08151 Boehringer Ingelheim Investigational Site
city: Hyogo, Akashi
country: Japan
facility: 1200.131.08161 Boehringer Ingelheim Investigational Site
city: Hyogo, Kobe
country: Japan
facility: 1200.131.08157 Boehringer Ingelheim Investigational Site
city: Kanagawa, Isehara
country: Japan
facility: 1200.131.08159 Boehringer Ingelheim Investigational Site
city: Miyagi, Natori
country: Japan
facility: 1200.131.08164 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1200.131.08160 Boehringer Ingelheim Investigational Site
city: Shizuoka, Sunto-gun
country: Japan
facility: 1200.131.08155 Boehringer Ingelheim Investigational Site
city: Tochigi, Shimotsuke
country: Japan
facility: 1200.131.08152 Boehringer Ingelheim Investigational Site
city: Tokyo, Koto-ku
country: Japan
facility: 1200.131.08163 Boehringer Ingelheim Investigational Site
city: Tokyo, Meguro-ku
country: Japan
facility: 1200.131.08154 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1200.131.05252 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1200.131.03152 Boehringer Ingelheim Investigational Site
city: Leiden
country: Netherlands
facility: 1200.131.03153 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1200.131.03151 Boehringer Ingelheim Investigational Site
city: Almada
country: Portugal
facility: 1200.131.35155 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1200.131.35154 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1200.131.35153 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 1200.131.35151 Boehringer Ingelheim Investigational Site
city: Évora
country: Portugal
facility: 1200.131.35152 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1200.131.00759 Boehringer Ingelheim Investigational Site
city: Omsk
country: Russian Federation
facility: 1200.131.00753 Boehringer Ingelheim Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: 1200.131.00760 Boehringer Ingelheim Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: 1200.131.00761 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1200.131.00763 Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: 1200.131.00755 Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: 1200.131.00762 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1200.131.03451 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1200.131.03454 Boehringer Ingelheim Investigational Site
city: Girona
country: Spain
facility: 1200.131.03463 Boehringer Ingelheim Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: 1200.131.03452 Boehringer Ingelheim Investigational Site
city: Lugo
country: Spain
facility: 1200.131.03459 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1200.131.03457 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1200.131.03464 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1200.131.03465 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1200.131.03456 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1200.131.03462 Boehringer Ingelheim Investigational Site
city: Pamplona
country: Spain
facility: 1200.131.03455 Boehringer Ingelheim Investigational Site
city: Pozuelo De Alarcón, Madrid
country: Spain
facility: 1200.131.03460 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1200.131.03466 Boehringer Ingelheim Investigational Site
city: Zaragoza
country: Spain
facility: 1200.131.03458 Boehringer Ingelheim Investigational Site
city: Ávila
country: Spain
facility: 1200.131.03461 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1200.131.04652 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1200.131.04651 Boehringer Ingelheim Investigational Site
city: Basel
country: Switzerland
facility: 1200.131.04151 Boehringer Ingelheim Investigational Site
city: Bern
country: Switzerland
facility: 1200.131.04152 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1200.131.03854 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1200.131.03851 Boehringer Ingelheim Investigational Site
city: Denbighshire
country: United Kingdom
facility: 1200.131.04456 Boehringer Ingelheim Investigational Site
city: Edinburgh
country: United Kingdom
facility: 1200.131.04455 Boehringer Ingelheim Investigational Site
city: Exeter
country: United Kingdom
facility: 1200.131.04459 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1200.131.04460 Boehringer Ingelheim Investigational Site
city: Leicester
country: United Kingdom
facility: 1200.131.04453 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1200.131.04451 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1200.131.04452 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 1200.131.04454 Boehringer Ingelheim Investigational Site
city: Sutton
country: United Kingdom
facility: 1200.131.04458 Boehringer Ingelheim Investigational Site
city: Whitchurch, Cardiff
country: United Kingdom
facility: 1200.131.04457 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.
citation: Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.