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

NCT ID: NCT01345669

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 617 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-17
• Study Completion Date: 2016-09-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Afatinib (BIBW 2992)

Once daily

Group Type: EXPERIMENTAL

Afatinib

Intervention Type: DRUG

Once daily

Placebo

Once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily

Interventions

Placebo

Once daily

Intervention Type: DRUG

Afatinib

Once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1200.131.00171 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

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Orange, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Winston-Salem, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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San Antonio, Texas, United States

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Spokane Valley, Washington, United States

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Wenatchee, Washington, United States

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Ciudad Autonoma de Bs As, , Argentina

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Córdoba, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Villa Domínico, , Argentina

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Wooloongabba, Queensland, Australia

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Leoben, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Charleroi, , Belgium

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Hasselt, , Belgium

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Kortrijk, , Belgium

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Liège, , Belgium

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Liège, , Belgium

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Namur, , Belgium

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Barretos, , Brazil

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Jaú, , Brazil

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Passo Fundo, , Brazil

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Porto Alegre, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Vina de Mar, , Chile

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Viña del Mar, , Chile

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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København Ø, , Denmark

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Alexandria, , Egypt

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Turku, , Finland

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Le Havre, , France

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Marseille, , France

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Nice, , France

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Orléans, , France

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Pierre-Bénite, , France

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Rouen, , France

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Saint-Cloud, , France

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Saint-Herblain, , France

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Saint-Priest-en-Jarez, , France

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Salouël, , France

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Tours, , France

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Villejuif, , France

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Essen, , Germany

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Freiburg im Breisgau, , Germany

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Hanover, , Germany

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Jena, , Germany

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Kaiserslautern, , Germany

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Leipzig, , Germany

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Rostock, , Germany

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Trier, , Germany

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Ulm, , Germany

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Villingen-Schwenningen, , Germany

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Chaïdári, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Budapest, , Hungary

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Budpest, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Ahmadābād, , India

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Bangalore, , India

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Bikaner, , India

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Chennai, , India

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Chennai, , India

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Delhi, , India

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Gurgaon, , India

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Hyderabad, , India

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Jaipur, , India

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Karamsad,Anand, Gujarat, , India

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Madurai, Tamil Nadu, , India

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Mazagaon, Mumbai, , India

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New Delhi, , India

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Pune, , India

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Visakhapatnam, , India

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Haifa, , Israel

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Petah Tikva, , Israel

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Confreria (CN), , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Aichi, Nagoya, , Japan

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Chiba, Kashiwa, , Japan

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Hokkaido, Sapporo, , Japan

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Hyogo, Akashi, , Japan

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Hyogo, Kobe, , Japan

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Kanagawa, Isehara, , Japan

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Miyagi, Natori, , Japan

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Osaka, Osaka, , Japan

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Shizuoka, Sunto-gun, , Japan

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Tochigi, Shimotsuke, , Japan

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Tokyo, Koto-ku, , Japan

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Tokyo, Meguro-ku, , Japan

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México, , Mexico

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Amsterdam, , Netherlands

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Leiden, , Netherlands

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Rotterdam, , Netherlands

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Almada, , Portugal

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Coimbra, , Portugal

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Evora, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Moscow, , Russia

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Omsk, , Russia

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Pyatigorsk, , Russia

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Pyatigorsk, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Ufa, , Russia

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Ávila, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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L'Hospitalet de Llobregat, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Málaga, , Spain

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Pamplona, , Spain

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Pozuelo de Alarcón, Madrid, , Spain

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Seville, , Spain

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Zaragoza, , Spain

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Gothenburg, , Sweden

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Stockholm, , Sweden

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Basel, , Switzerland

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Bern, , Switzerland

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Denbighshire, , United Kingdom

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Edinburgh, , United Kingdom

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Exeter, , United Kingdom

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Glasgow, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Sheffield, , United Kingdom

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Sutton, , United Kingdom

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Whitchurch, Cardiff, , United Kingdom

Countries

Poland; United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Czechia; Denmark; Egypt; Finland; France; Germany; Greece; Hungary; India; Israel; Italy; Japan; Mexico; Netherlands; Portugal; Russia; Spain; Sweden; Switzerland; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31194247 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25432788 (View on PubMed)

Other Identifiers

2011-000392-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.131

Identifier Type: -

Identifier Source: org_study_id