Head and Neck NeoplasmsPhase 3NCT01345669

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

A Phase 3 study testing Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 162 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Neoplasms
What is being tested?: Afatinib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 617 participants
Where: 162 sitesin 29 countries
Study dates: 17 Oct 2011to 12 Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

162 sites in 29 countries.

Country

City, postcode or hospital

162 sites in 29 countries

United States15 sites

1200.131.00177 Boehringer Ingelheim Investigational Site
Aurora, Colorado
1200.131.00173 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1200.131.00176 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1200.131.00175 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
1200.131.00171 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
1200.131.00185 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
1200.131.00182 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1200.131.00181 Boehringer Ingelheim Investigational Site
Orange, California
1200.131.00172 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1200.131.00184 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1200.131.00198 Boehringer Ingelheim Investigational Site
Spokane Valley, Washington
1200.131.00179 Boehringer Ingelheim Investigational Site
Stony Brook, New York
1200.131.00188 Boehringer Ingelheim Investigational Site
The Bronx, New York
1200.131.00183 Boehringer Ingelheim Investigational Site
Wenatchee, Washington
1200.131.10200 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

India15 sites

1200.131.09178 Boehringer Ingelheim Investigational Site
Ahmadābād
1200.131.09165 Boehringer Ingelheim Investigational Site
Bangalore
1200.131.09152 Boehringer Ingelheim Investigational Site
Bikaner
1200.131.09163 Boehringer Ingelheim Investigational Site
Chennai
1200.131.09173 Boehringer Ingelheim Investigational Site
Chennai
1200.131.09179 Boehringer Ingelheim Investigational Site
Delhi
1200.131.09170 Boehringer Ingelheim Investigational Site
Gūrgaon
1200.131.09180 Boehringer Ingelheim Investigational Site
Hyderabad
1200.131.09172 Boehringer Ingelheim Investigational Site
Jaipur
1200.131.09176 Boehringer Ingelheim Investigational Site
Karamsad,Anand, Gujarat
1200.131.09162 Boehringer Ingelheim Investigational Site
Madurai, Tamil Nadu
1200.131.09175 Boehringer Ingelheim Investigational Site
Mazagaon, Mumbai
1200.131.09151 Boehringer Ingelheim Investigational Site
New Delhi
1200.131.09164 Boehringer Ingelheim Investigational Site
Pune
1200.131.09159 Boehringer Ingelheim Investigational Site
Visakhapatnam

Other trials in India

Spain15 sites

1200.131.03461 Boehringer Ingelheim Investigational Site
Ávila
1200.131.03451 Boehringer Ingelheim Investigational Site
Barcelona
1200.131.03454 Boehringer Ingelheim Investigational Site
Barcelona
1200.131.03463 Boehringer Ingelheim Investigational Site
Girona
1200.131.03452 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1200.131.03459 Boehringer Ingelheim Investigational Site
Lugo
1200.131.03457 Boehringer Ingelheim Investigational Site
Madrid
1200.131.03464 Boehringer Ingelheim Investigational Site
Madrid
1200.131.03465 Boehringer Ingelheim Investigational Site
Madrid
1200.131.03456 Boehringer Ingelheim Investigational Site
Málaga
1200.131.03462 Boehringer Ingelheim Investigational Site
Málaga
1200.131.03455 Boehringer Ingelheim Investigational Site
Pamplona
1200.131.03460 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Madrid
1200.131.03466 Boehringer Ingelheim Investigational Site
Seville
1200.131.03458 Boehringer Ingelheim Investigational Site
Zaragoza

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France12 sites

1200.131.03353 Boehringer Ingelheim Investigational Site
Le Havre
1200.131.03362 Boehringer Ingelheim Investigational Site
Marseille
1200.131.03359 Boehringer Ingelheim Investigational Site
Nice
1200.131.03365 Boehringer Ingelheim Investigational Site
Orléans
1200.131.03355 Boehringer Ingelheim Investigational Site
Pierre-Bénite
1200.131.03367 Boehringer Ingelheim Investigational Site
Rouen
1200.131.03370 Boehringer Ingelheim Investigational Site
Saint-Cloud
1200.131.03354 Boehringer Ingelheim Investigational Site
Saint-Herblain
1200.131.03369 Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez
1200.131.03366 Boehringer Ingelheim Investigational Site
Salouël
1200.131.03356 Boehringer Ingelheim Investigational Site
Tours
1200.131.03357 Boehringer Ingelheim Investigational Site
Villejuif

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Japan12 sites

1200.131.08156 Boehringer Ingelheim Investigational Site
Aichi, Nagoya
1200.131.08153 Boehringer Ingelheim Investigational Site
Chiba, Kashiwa
1200.131.08151 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1200.131.08161 Boehringer Ingelheim Investigational Site
Hyogo, Akashi
1200.131.08157 Boehringer Ingelheim Investigational Site
Hyogo, Kobe
1200.131.08159 Boehringer Ingelheim Investigational Site
Kanagawa, Isehara
1200.131.08164 Boehringer Ingelheim Investigational Site
Miyagi, Natori
1200.131.08160 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1200.131.08155 Boehringer Ingelheim Investigational Site
Shizuoka, Sunto-gun
1200.131.08152 Boehringer Ingelheim Investigational Site
Tochigi, Shimotsuke
1200.131.08163 Boehringer Ingelheim Investigational Site
Tokyo, Koto-ku
1200.131.08154 Boehringer Ingelheim Investigational Site
Tokyo, Meguro-ku

Other trials in Japan

Germany10 sites

1200.131.04954 Boehringer Ingelheim Investigational Site
Essen
1200.131.04961 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1200.131.04953 Boehringer Ingelheim Investigational Site
Hanover
1200.131.04956 Boehringer Ingelheim Investigational Site
Jena
1200.131.04959 Boehringer Ingelheim Investigational Site
Kaiserslautern
1200.131.04951 Boehringer Ingelheim Investigational Site
Leipzig
1200.131.04957 Boehringer Ingelheim Investigational Site
Rostock
1200.131.04964 Boehringer Ingelheim Investigational Site
Trier
1200.131.04963 Boehringer Ingelheim Investigational Site
Ulm
1200.131.04962 Boehringer Ingelheim Investigational Site
Villingen-Schwenningen

Other trials in Germany

United Kingdom10 sites

1200.131.04456 Boehringer Ingelheim Investigational Site
Denbighshire
1200.131.04455 Boehringer Ingelheim Investigational Site
Edinburgh
1200.131.04459 Boehringer Ingelheim Investigational Site
Exeter
1200.131.04460 Boehringer Ingelheim Investigational Site
Glasgow
1200.131.04453 Boehringer Ingelheim Investigational Site
Leicester
1200.131.04451 Boehringer Ingelheim Investigational Site
London
1200.131.04452 Boehringer Ingelheim Investigational Site
Manchester
1200.131.04454 Boehringer Ingelheim Investigational Site
Sheffield
1200.131.04458 Boehringer Ingelheim Investigational Site
Sutton
1200.131.04457 Boehringer Ingelheim Investigational Site
Whitchurch, Cardiff

Other trials in United Kingdom

Belgium7 sites

1200.131.03259 Boehringer Ingelheim Investigational Site
Brussels
1200.131.03256 Boehringer Ingelheim Investigational Site
Charleroi
1200.131.03255 Boehringer Ingelheim Investigational Site
Hasselt
1200.131.03253 Boehringer Ingelheim Investigational Site
Kortrijk
1200.131.03252 Boehringer Ingelheim Investigational Site
Liège
1200.131.03254 Boehringer Ingelheim Investigational Site
Liège
1200.131.03258 Boehringer Ingelheim Investigational Site
Namur

Other trials in Belgium

Russia7 sites

1200.131.00759 Boehringer Ingelheim Investigational Site
Moscow
1200.131.00753 Boehringer Ingelheim Investigational Site
Omsk
1200.131.00760 Boehringer Ingelheim Investigational Site
Pyatigorsk
1200.131.00761 Boehringer Ingelheim Investigational Site
Pyatigorsk
1200.131.00763 Boehringer Ingelheim Investigational Site
Saint Petersburg
1200.131.00755 Boehringer Ingelheim Investigational Site
Ufa
1200.131.00762 Boehringer Ingelheim Investigational Site
Ufa

Other trials in Russia

Brazil6 sites

1200.131.05554 Boehringer Ingelheim Investigational Site
Barretos
1200.131.05555 Boehringer Ingelheim Investigational Site
Jaú
1200.131.05557 Boehringer Ingelheim Investigational Site
Passo Fundo
1200.131.05553 Boehringer Ingelheim Investigational Site
Porto Alegre
1200.131.05551 Boehringer Ingelheim Investigational Site
São Paulo
1200.131.05556 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Canada6 sites

1200.131.00153 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1200.131.00154 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1200.131.00155 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1200.131.00157 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1200.131.00152 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1200.131.00151 Boehringer Ingelheim Investigational Site
Windsor, Ontario

Other trials in Canada

Argentina5 sites

1200.131.05451 Boehringer Ingelheim Investigational Site
Ciudad Autonoma de Bs As
1200.131.05457 Boehringer Ingelheim Investigational Site
Córdoba
1200.131.05458 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
1200.131.05452 Boehringer Ingelheim Investigational Site
Santa Fe
1200.131.05453 Boehringer Ingelheim Investigational Site
Villa Domínico

Other trials in Argentina

Austria5 sites

1200.131.04353 Boehringer Ingelheim Investigational Site
Leoben
1200.131.04357 Boehringer Ingelheim Investigational Site
Linz
1200.131.04355 Boehringer Ingelheim Investigational Site
Salzburg
1200.131.04351 Boehringer Ingelheim Investigational Site
Vienna
1200.131.04359 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Hungary5 sites

1200.131.03651 Boehringer Ingelheim Investigational Site
Budapest
1200.131.03652 Boehringer Ingelheim Investigational Site
Budapest
1200.131.03656 Boehringer Ingelheim Investigational Site
Budpest
1200.131.03654 Boehringer Ingelheim Investigational Site
Debrecen
1200.131.03655 Boehringer Ingelheim Investigational Site
Kecskemét

Other trials in Hungary

Portugal5 sites

1200.131.35155 Boehringer Ingelheim Investigational Site
Almada
1200.131.35154 Boehringer Ingelheim Investigational Site
Coimbra
1200.131.35152 Boehringer Ingelheim Investigational Site
Evora
1200.131.35153 Boehringer Ingelheim Investigational Site
Lisbon
1200.131.35151 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Italy4 sites

1200.131.03957 Boehringer Ingelheim Investigational Site
Confreria (CN)
1200.131.03951 Boehringer Ingelheim Investigational Site
Milan
1200.131.03955 Boehringer Ingelheim Investigational Site
Milan
1200.131.03960 Boehringer Ingelheim Investigational Site
Milan

Other trials in Italy

Czechia3 sites

1200.131.04254 Boehringer Ingelheim Investigational Site
Brno
1200.131.04251 Boehringer Ingelheim Investigational Site
Prague
1200.131.04253 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Netherlands3 sites

1200.131.03152 Boehringer Ingelheim Investigational Site
Amsterdam
1200.131.03153 Boehringer Ingelheim Investigational Site
Leiden
1200.131.03151 Boehringer Ingelheim Investigational Site
Rotterdam

Other trials in Netherlands

Chile2 sites

1200.131.05652 Boehringer Ingelheim Investigational Site
Vina de Mar
1200.131.05651 Boehringer Ingelheim Investigational Site
Viña del Mar

Other trials in Chile

Greece2 sites

1200.131.03054 Boehringer Ingelheim Investigational Site
Chaïdári
1200.131.03052 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Israel2 sites

1200.131.97251 Boehringer Ingelheim Investigational Site
Haifa
1200.131.97253 Boehringer Ingelheim Investigational Site
Petah Tikva

Other trials in Israel

Sweden2 sites

1200.131.04652 Boehringer Ingelheim Investigational Site
Gothenburg
1200.131.04651 Boehringer Ingelheim Investigational Site
Stockholm

Other trials in Sweden

Switzerland2 sites

1200.131.04151 Boehringer Ingelheim Investigational Site
Basel
1200.131.04152 Boehringer Ingelheim Investigational Site
Bern

Other trials in Switzerland

Ukraine2 sites

1200.131.03854 Boehringer Ingelheim Investigational Site
Kharkiv
1200.131.03851 Boehringer Ingelheim Investigational Site
Kiev

Other trials in Ukraine

Australia1 site

1200.131.06151 Boehringer Ingelheim Investigational Site
Wooloongabba, Queensland

Other trials in Australia

Denmark1 site

1200.131.04551 Boehringer Ingelheim Investigational Site
København Ø

Other trials in Denmark

Egypt1 site

1200.131.2052 Boehringer Ingelheim Investigational Site
Alexandria

Other trials in Egypt

Finland1 site

1200.131.35851 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

Mexico1 site

1200.131.05252 Boehringer Ingelheim Investigational Site
México

Other trials in Mexico

About this study

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

Conditions: Head and Neck Neoplasms
Being tested: Placebo, Afatinib
Medical subject headings: Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Once daily
AfatinibDrug
Once daily

Study groups in NCT01345669
Study group	Role	What they receive
Afatinib (BIBW 2992)	Experimental	Once daily Receives: Drug: Afatinib
Placebo	Placebo comparator	Once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 5 years

Secondary outcomes (5)

Disease Free Survival (DFS) Rate at 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.
Measured: Up to 2 years
Percentage of Patient Deaths (Overall Survival (OS))
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.
Measured: Up to 5 years
Patients With Improved Health Related Quality of Life (HRQOL)
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.
Measured: Up to 5 years
Time to Deterioration in Health Related Quality of Life (HRQOL)
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.
Measured: Up to 5 years
Health Related Quality of Life (HRQOL) Scores Over Time
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.
Measured: Baseline and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201112 Sep 2016

First posted2 May 2011 (estimated)
Study start17 Oct 2011
Primary completion12 Sep 2016
Study completion12 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 617 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01345669
Sponsor's protocol ID: 1200.131
Other IDs: 2011-000392-14
Status last verified: Nov 2017
First submitted: 28 Apr 2011
Last updated: 7 Dec 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 31194247
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.
PubMed 25432788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Head and Neck Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01345669
Acronym / sponsor ID: 1200.131
Conditions: Head and Neck Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 617 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Oct 2011 (actual)
Primary completion: 12 Sep 2016 (actual)
Study completion: 12 Sep 2016 (actual)
First posted: 2 May 2011 (estimated)
Results: Posted 23 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Afatinib (BIBW 2992)	Experimental	Drug: AfatinibOnce daily
Placebo	Placebo comparator	Drug: PlaceboOnce daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboOnce daily	Drug	Placebo
AfatinibOnce daily	Drug	Afatinib (BIBW 2992)

Primary outcome

Disease Free Survival (DFS)
Time frame: 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.

5 secondary outcomes

Disease Free Survival (DFS) Rate at 2 Years
Time frame: Up to 2 years
Percentage of Patient Deaths (Overall Survival (OS))
Time frame: Up to 5 years
Patients With Improved Health Related Quality of Life (HRQOL)
Time frame: Up to 5 years
Time to Deterioration in Health Related Quality of Life (HRQOL)
Time frame: Up to 5 years
Health Related Quality of Life (HRQOL) Scores Over Time
Time frame: Baseline and 5 years

Results and safety

Results posted to the registry on 23 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib (BIBW 2992)	411	124
Placebo	206	87

Primary outcome: Disease Free Survival (DFS)

Time frame: Up to 5 years. Median (Inter-Quartile Range). Unit: Months

Measure	Afatinib (BIBW 2992) n = 411	Placebo n = 206
Value	43.40 (16.82 to NA)	NA (16.69 to NA)

Afatinib (BIBW 2992) vs Placebo: Hazard Ratio (HR): 1.126 (95% CI 0.809 to 1.569), p = 0.4806, Log Rank

Population analysed: Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 4 weeks after the last drug administration, up to 84 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib (BIBW 2992)	80 of 411 (19.5%)	407 of 411 (99%)	Not reported
Placebo	51 of 206 (24.8%)	169 of 206 (82%)	Not reported

Limitations and caveats (from the sponsor): The trial was stopped prematurely due to futility.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31194247Burtness 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.
Derived from this study: PubMed 25432788Burtness 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

162 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 162 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, India, Spain, France, Japan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01345669, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.