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

NCT01345669 | Terminated Phase 3 Results

• 2 other identifiers: 1200.1312011-000392-14
• Study Type: interventional
• Target: 617
• Locations: 28 countries
• Sites: 161

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS)

  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 Outcomes (5)

• Disease Free Survival (DFS) Rate at 2 Years

  Up to 2 years

• Percentage of Patient Deaths (Overall Survival (OS))

  Up to 5 years

• Patients With Improved Health Related Quality of Life (HRQOL)

  Up to 5 years

• Time to Deterioration in Health Related Quality of Life (HRQOL)

  Up to 5 years

• Health Related Quality of Life (HRQOL) Scores Over Time

  Baseline and 5 years

Study Arms (2)

Afatinib (BIBW 2992)

EXPERIMENTAL

Once daily

Drug: Afatinib

Placebo

PLACEBO COMPARATOR

Once daily

Drug: Placebo

Interventions

Placebo DRUG

Once daily

Placebo

Afatinib DRUG

Once daily

Afatinib (BIBW 2992)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
• 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
• 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
• Known pre-existing Interstitial Lung Disease (ILD)
• Pregnancy or breast feeding

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (162)

1200.131.00171 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

1200.131.00181 Boehringer Ingelheim Investigational Site

Orange, California, United States

Location

1200.131.00177 Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Location

1200.131.00185 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Location

1200.131.00173 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1200.131.00176 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1200.131.00182 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1200.131.00175 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

1200.131.00179 Boehringer Ingelheim Investigational Site

Stony Brook, New York, United States

Location

1200.131.00188 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

1200.131.10200 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1200.131.00172 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1200.131.00184 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1200.131.00198 Boehringer Ingelheim Investigational Site

Spokane Valley, Washington, United States

Location

1200.131.00183 Boehringer Ingelheim Investigational Site

Wenatchee, Washington, United States

Location

1200.131.05451 Boehringer Ingelheim Investigational Site

Ciudad Autonoma de Bs As, Argentina

Location

1200.131.05457 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Location

1200.131.05458 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, Argentina

Location

1200.131.05452 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

Location

1200.131.05453 Boehringer Ingelheim Investigational Site

Villa Domínico, Argentina

Location

1200.131.06151 Boehringer Ingelheim Investigational Site

Wooloongabba, Queensland, Australia

Location

1200.131.04353 Boehringer Ingelheim Investigational Site

Leoben, Austria

Location

1200.131.04357 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1200.131.04355 Boehringer Ingelheim Investigational Site

Salzburg, Austria

Location

1200.131.04351 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1200.131.04359 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1200.131.03259 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1200.131.03256 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1200.131.03255 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1200.131.03253 Boehringer Ingelheim Investigational Site

Kortrijk, Belgium

Location

1200.131.03252 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1200.131.03254 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1200.131.03258 Boehringer Ingelheim Investigational Site

Namur, Belgium

Location

1200.131.05554 Boehringer Ingelheim Investigational Site

Barretos, Brazil

Location

1200.131.05555 Boehringer Ingelheim Investigational Site

Jaú, Brazil

Location

1200.131.05557 Boehringer Ingelheim Investigational Site

Passo Fundo, Brazil

Location

1200.131.05553 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1200.131.05551 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1200.131.05556 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1200.131.00152 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1200.131.00157 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1200.131.00151 Boehringer Ingelheim Investigational Site

Windsor, Ontario, Canada

Location

1200.131.00153 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1200.131.00154 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1200.131.00155 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1200.131.05652 Boehringer Ingelheim Investigational Site

Vina de Mar, Chile

Location

1200.131.05651 Boehringer Ingelheim Investigational Site

Viña del Mar, Chile

Location

1200.131.04254 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1200.131.04251 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1200.131.04253 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1200.131.04551 Boehringer Ingelheim Investigational Site

København Ø, Denmark

Location

1200.131.2052 Boehringer Ingelheim Investigational Site

Alexandria, Egypt

Location

1200.131.35851 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1200.131.03353 Boehringer Ingelheim Investigational Site

Le Havre, France

Location

1200.131.03362 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1200.131.03359 Boehringer Ingelheim Investigational Site

Nice, France

Location

1200.131.03365 Boehringer Ingelheim Investigational Site

Orléans, France

Location

1200.131.03355 Boehringer Ingelheim Investigational Site

Pierre-Bénite, France

Location

1200.131.03367 Boehringer Ingelheim Investigational Site

Rouen, France

Location

1200.131.03370 Boehringer Ingelheim Investigational Site

Saint-Cloud, France

Location

1200.131.03354 Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

1200.131.03369 Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

Location

1200.131.03366 Boehringer Ingelheim Investigational Site

Salouël, France

Location

1200.131.03356 Boehringer Ingelheim Investigational Site

Tours, France

Location

1200.131.03357 Boehringer Ingelheim Investigational Site

Villejuif, France

Location

1200.131.04954 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1200.131.04961 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1200.131.04953 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1200.131.04956 Boehringer Ingelheim Investigational Site

Jena, Germany

Location

1200.131.04959 Boehringer Ingelheim Investigational Site

Kaiserslautern, Germany

Location

1200.131.04951 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

1200.131.04957 Boehringer Ingelheim Investigational Site

Rostock, Germany

Location

1200.131.04964 Boehringer Ingelheim Investigational Site

Trier, Germany

Location

1200.131.04963 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

1200.131.04962 Boehringer Ingelheim Investigational Site

Villingen-Schwenningen, Germany

Location

1200.131.03054 Boehringer Ingelheim Investigational Site

Chaïdári, Greece

Location

1200.131.03052 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1200.131.03651 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1200.131.03652 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1200.131.03656 Boehringer Ingelheim Investigational Site

Budpest, Hungary

Location

1200.131.03654 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1200.131.03655 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

1200.131.09178 Boehringer Ingelheim Investigational Site

Ahmadābād, India

Location

1200.131.09165 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1200.131.09152 Boehringer Ingelheim Investigational Site

Bikaner, India

Location

1200.131.09163 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1200.131.09173 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1200.131.09179 Boehringer Ingelheim Investigational Site

Delhi, India

Location

1200.131.09170 Boehringer Ingelheim Investigational Site

Gūrgaon, India

Location

1200.131.09180 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1200.131.09172 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1200.131.09176 Boehringer Ingelheim Investigational Site

Karamsad,Anand, Gujarat, India

Location

1200.131.09162 Boehringer Ingelheim Investigational Site

Madurai, Tamil Nadu, India

Location

1200.131.09175 Boehringer Ingelheim Investigational Site

Mazagaon, Mumbai, India

Location

1200.131.09151 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1200.131.09164 Boehringer Ingelheim Investigational Site

Pune, India

Location

1200.131.09159 Boehringer Ingelheim Investigational Site

Visakhapatnam, India

Location

1200.131.97251 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1200.131.97253 Boehringer Ingelheim Investigational Site

Petah Tikva, Israel

Location

1200.131.03957 Boehringer Ingelheim Investigational Site

Confreria (CN), Italy

Location

1200.131.03951 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1200.131.03955 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1200.131.03960 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1200.131.08156 Boehringer Ingelheim Investigational Site

Aichi, Nagoya, Japan

Location

1200.131.08153 Boehringer Ingelheim Investigational Site

Chiba, Kashiwa, Japan

Location

1200.131.08151 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

Location

1200.131.08161 Boehringer Ingelheim Investigational Site

Hyogo, Akashi, Japan

Location

1200.131.08157 Boehringer Ingelheim Investigational Site

Hyogo, Kobe, Japan

Location

1200.131.08159 Boehringer Ingelheim Investigational Site

Kanagawa, Isehara, Japan

Location

1200.131.08164 Boehringer Ingelheim Investigational Site

Miyagi, Natori, Japan

Location

1200.131.08160 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1200.131.08155 Boehringer Ingelheim Investigational Site

Shizuoka, Sunto-gun, Japan

Location

1200.131.08152 Boehringer Ingelheim Investigational Site

Tochigi, Shimotsuke, Japan

Location

1200.131.08163 Boehringer Ingelheim Investigational Site

Tokyo, Koto-ku, Japan

Location

1200.131.08154 Boehringer Ingelheim Investigational Site

Tokyo, Meguro-ku, Japan

Location

1200.131.05252 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1200.131.03152 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1200.131.03153 Boehringer Ingelheim Investigational Site

Leiden, Netherlands

Location

1200.131.03151 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1200.131.35155 Boehringer Ingelheim Investigational Site

Almada, Portugal

Location

1200.131.35154 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1200.131.35152 Boehringer Ingelheim Investigational Site

Evora, Portugal

Location

1200.131.35153 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1200.131.35151 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1200.131.00759 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1200.131.00753 Boehringer Ingelheim Investigational Site

Omsk, Russia

Location

1200.131.00760 Boehringer Ingelheim Investigational Site

Pyatigorsk, Russia

Location

1200.131.00761 Boehringer Ingelheim Investigational Site

Pyatigorsk, Russia

Location

1200.131.00763 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1200.131.00755 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1200.131.00762 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1200.131.03461 Boehringer Ingelheim Investigational Site

Ávila, Spain

Location

1200.131.03451 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1200.131.03454 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1200.131.03463 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

1200.131.03452 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1200.131.03459 Boehringer Ingelheim Investigational Site

Lugo, Spain

Location

1200.131.03457 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.131.03464 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.131.03465 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.131.03456 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1200.131.03462 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1200.131.03455 Boehringer Ingelheim Investigational Site

Pamplona, Spain

Location

1200.131.03460 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, Madrid, Spain

Location

1200.131.03466 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1200.131.03458 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

1200.131.04652 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1200.131.04651 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1200.131.04151 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

1200.131.04152 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1200.131.03854 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1200.131.03851 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1200.131.04456 Boehringer Ingelheim Investigational Site

Denbighshire, United Kingdom

Location

1200.131.04455 Boehringer Ingelheim Investigational Site

Edinburgh, United Kingdom

Location

1200.131.04459 Boehringer Ingelheim Investigational Site

Exeter, United Kingdom

Location

1200.131.04460 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1200.131.04453 Boehringer Ingelheim Investigational Site

Leicester, United Kingdom

Location

1200.131.04451 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1200.131.04452 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1200.131.04454 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

1200.131.04458 Boehringer Ingelheim Investigational Site

Sutton, United Kingdom

Location

1200.131.04457 Boehringer Ingelheim Investigational Site

Whitchurch, Cardiff, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31194247 DERIVED

• 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.

  PMID: 25432788 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The trial was stopped prematurely due to futility.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: October 17, 2011
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: December 7, 2017
• Results First Posted: October 23, 2017

Record last verified: 2017-11

Locations

IN (15); UA (2); NL (3); AU (5); CL (2); RU (7); BR (6); CH (2); IL (2); ES (15); CA (6); HU (5); AR (5); JP (12); PT (5); BE (7); CZ (3); GR (2); US (15); EG (1); SE (2); GB (10); FI (1); DK (1); DE (10); FR (12); IT (4); ME (1)