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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01345669




Registration number
NCT01345669
Ethics application status
Date submitted
28/04/2011
Date registered
2/05/2011
Date last updated
7/12/2017

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2011-000392-14
Secondary ID [2] 0 0
1200.131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Afatinib

Experimental: Afatinib (BIBW 2992) - Once daily

Placebo comparator: Placebo - Once daily


Treatment: Drugs: Placebo
Once daily

Treatment: Drugs: Afatinib
Once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Disease Free Survival (DFS) Rate at 2 Years
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Percentage of Patient Deaths (Overall Survival (OS))
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Patients With Improved Health Related Quality of Life (HRQOL)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Time to Deterioration in Health Related Quality of Life (HRQOL)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Health Related Quality of Life (HRQOL) Scores Over Time
Timepoint [5] 0 0
Baseline and 5 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/09/2016
Sample size
Target
Accrual to date
Final
617
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
1200.131.06151 Boehringer Ingelheim Investigational Site - Wooloongabba
Recruitment postcode(s) [1] 0 0
- Wooloongabba
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arkansas
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California
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Colorado
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Connecticut
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Maryland
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Washington
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Argentina
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Ciudad Autonoma de Bs As
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Argentina
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Cordoba
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San Miguel de Tucuman
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Santa Fe
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Brussel
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Charleroi
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Hasselt
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Villingen-Schwenningen
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Osaka, Osaka
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Ávila
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Stockholm
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Switzerland
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Basel
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Switzerland
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Bern
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Ukraine
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Kharkiv
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Kiev
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Denbighshire
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Exeter
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Glasgow
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Leicester
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London
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Manchester
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Sutton
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Whitchurch, Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01345669
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01345669