LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

NCT ID: NCT01345682

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-05
• Study Completion Date: 2016-12-06

Brief Summary

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afatinib (BIBW 2992)

Once daily

Group Type: EXPERIMENTAL

Afatinib

Intervention Type: DRUG

Once daily

Methotrexate

Weekly

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

Weekly

Interventions

Afatinib

Once daily

Intervention Type: DRUG

Methotrexate

Weekly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy

2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease

3. Measurable disease according to RECIST

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC

2. Any other than one previous platinum based systemic regimen given for R/M disease

3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules

4. 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

1200.43.00113 Boehringer Ingelheim Investigational Site

Harvey, Illinois, United States

1200.43.00106 Boehringer Ingelheim Investigational Site

Peoria, Illinois, United States

1200.43.00110 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

1200.43.00107 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1200.43.00105 Boehringer Ingelheim Investigational Site

Stony Brook, New York, United States

1200.43.00102 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1200.43.00103 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1200.43.00109 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1200.43.05401 Boehringer Ingelheim Investigational Site

Ciudad Autonoma de Bs As, , Argentina

1200.43.05402 Boehringer Ingelheim Investigational Site

Santa Fe, , Argentina

1200.43.05403 Boehringer Ingelheim Investigational Site

Villa Domínico, , Argentina

1200.43.04303 Boehringer Ingelheim Investigational Site

Leoben, , Austria

1200.43.04305 Boehringer Ingelheim Investigational Site

Salzburg, , Austria

1200.43.04301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1200.43.03202 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1200.43.03203 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

1200.43.03204 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

1200.43.03201 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1200.43.05504 Boehringer Ingelheim Investigational Site

Barretos, , Brazil

1200.43.05505 Boehringer Ingelheim Investigational Site

Jaú, , Brazil

1200.43.05507 Boehringer Ingelheim Investigational Site

Passo Fundo, , Brazil

1200.43.05503 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

1200.43.05502 Boehringer Ingelheim Investigational Site

Rio de Janeiro, , Brazil

1200.43.05501 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

1200.43.05506 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

1200.43.04202 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

1200.43.04201 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1200.43.04203 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1200.43.04501 Boehringer Ingelheim Investigational Site

København Ø, , Denmark

1200.43.03304 Boehringer Ingelheim Investigational Site

Avignon, , France

1200.43.03306 Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

1200.43.03312 Boehringer Ingelheim Investigational Site

Dijon, , France

1200.43.03303 Boehringer Ingelheim Investigational Site

Lille, , France

1200.43.03301 Boehringer Ingelheim Investigational Site

Lyon, , France

1200.43.03302 Boehringer Ingelheim Investigational Site

Montpellier, , France

1200.43.03307 Boehringer Ingelheim Investigational Site

Nice, , France

1200.43.03314 Boehringer Ingelheim Investigational Site

Paris, , France

1200.43.03305 Boehringer Ingelheim Investigational Site

Poitiers, , France

1200.43.03316 Boehringer Ingelheim Investigational Site

Rouen, , France

1200.43.03309 Boehringer Ingelheim Investigational Site

Saint-Herblain, , France

1200.43.03310 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

1200.43.03317 Boehringer Ingelheim Investigational Site

Villejuif, , France

1200.43.04903 Boehringer Ingelheim Investigational Site

Aachen, , Germany

1200.43.04902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1200.43.04909 Boehringer Ingelheim Investigational Site

Dresden, , Germany

1200.43.04901 Boehringer Ingelheim Investigational Site

Essen, , Germany

1200.43.04905 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

1200.43.04906 Boehringer Ingelheim Investigational Site

Hanover, , Germany

1200.43.04908 Boehringer Ingelheim Investigational Site

Jena, , Germany

1200.43.04904 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

1200.43.04907 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

1200.43.03004 Boehringer Ingelheim Investigational Site

Haidari, , Greece

1200.43.03005 Boehringer Ingelheim Investigational Site

Heraklion, , Greece

1200.43.03002 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

1200.43.97201 Boehringer Ingelheim Investigational Site

Haifa, , Israel

1200.43.97203 Boehringer Ingelheim Investigational Site

Petah Tikva, , Israel

1200.43.97204 Boehringer Ingelheim Investigational Site

Tel Litwinsky, , Israel

1200.43.03909 Boehringer Ingelheim Investigational Site

Aosta, , Italy

1200.43.03908 Boehringer Ingelheim Investigational Site

Cagliari, , Italy

1200.43.03901 Boehringer Ingelheim Investigational Site

Confreria (CN), , Italy

1200.43.03907 Boehringer Ingelheim Investigational Site

Milan, , Italy

1200.43.03903 Boehringer Ingelheim Investigational Site

Napoli, , Italy

1200.43.03905 Boehringer Ingelheim Investigational Site

Palermo, , Italy

1200.43.03902 Boehringer Ingelheim Investigational Site

Savona, , Italy

1200.43.03904 Boehringer Ingelheim Investigational Site

Taormina (ME), , Italy

1200.43.03906 Boehringer Ingelheim Investigational Site

Venezia, , Italy

1200.43.03910 Boehringer Ingelheim Investigational Site

Viterbo, , Italy

1200.43.08106 Boehringer Ingelheim Investigational Site

Aichi, Nagoya, , Japan

1200.43.08103 Boehringer Ingelheim Investigational Site

Chiba, Kashiwa, , Japan

1200.43.08108 Boehringer Ingelheim Investigational Site

Ehime, Matsuyama, , Japan

1200.43.08111 Boehringer Ingelheim Investigational Site

Hyogo, Akashi, , Japan

1200.43.08107 Boehringer Ingelheim Investigational Site

Hyogo, Kobe, , Japan

1200.43.08109 Boehringer Ingelheim Investigational Site

Kanagawa, Isehara, , Japan

1200.43.08114 Boehringer Ingelheim Investigational Site

Miyagi, Natori, , Japan

1200.43.08110 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1200.43.08105 Boehringer Ingelheim Investigational Site

Shizuoka, Sunto-gun, , Japan

1200.43.08102 Boehringer Ingelheim Investigational Site

Tochigi, Shimotsuke, , Japan

1200.43.08113 Boehringer Ingelheim Investigational Site

Tokyo, Koto-ku, , Japan

1200.43.08104 Boehringer Ingelheim Investigational Site

Tokyo, Meguro-ku, , Japan

1200.43.08112 Boehringer Ingelheim Investigational Site

Tokyo, Minato-ku, , Japan

1200.43.05202 Boehringer Ingelheim Investigational Site

México, , Mexico

1200.43.00704 Boehringer Ingelheim Investigational Site

Ivanovo, , Russia

1200.43.00706 Boehringer Ingelheim Investigational Site

Kurski, , Russia

1200.43.00709 Boehringer Ingelheim Investigational Site

Moscow, , Russia

1200.43.00703 Boehringer Ingelheim Investigational Site

Omsk, , Russia

1200.43.00710 Boehringer Ingelheim Investigational Site

Pyatigorsk, , Russia

1200.43.00707 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

1200.43.00705 Boehringer Ingelheim Investigational Site

Ufa, , Russia

1200.43.02703 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1200.43.02704 Boehringer Ingelheim Investigational Site

Kraaifontein, Cape Town, , South Africa

1200.43.02701 Boehringer Ingelheim Investigational Site

Parktown, Johannesburg, , South Africa

1200.43.02702 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

1200.43.03401 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1200.43.03404 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1200.43.03405 Boehringer Ingelheim Investigational Site

Girona, , Spain

1200.43.03406 Boehringer Ingelheim Investigational Site

Málaga, , Spain

1200.43.03402 Boehringer Ingelheim Investigational Site

Salamanca, , Spain

1200.43.03403 Boehringer Ingelheim Investigational Site

Zaragoza, , Spain

1200.43.04602 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

1200.43.04101 Boehringer Ingelheim Investigational Site

Basel, , Switzerland

1200.43.04102 Boehringer Ingelheim Investigational Site

Bern, , Switzerland

Countries

United States; Argentina; Austria; Belgium; Brazil; Czechia; Denmark; France; Germany; Greece; Israel; Italy; Japan; Mexico; Russia; South Africa; Spain; Sweden; Switzerland

References

Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, Del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Kramer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels JH. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Ann Oncol. 2017 Oct 1;28(10):2526-2532. doi: 10.1093/annonc/mdx344.

Reference Type: DERIVED

PMID: 28961833 (View on PubMed)

Clement PM, Gauler T, Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB; LUX-H&N 1 investigators. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial. Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.

Reference Type: DERIVED

PMID: 27084954 (View on PubMed)

Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE; LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.

Reference Type: DERIVED

PMID: 25892145 (View on PubMed)

Other Identifiers

2011-000391-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.43

Identifier Type: -

Identifier Source: org_study_id