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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - 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.
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
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.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Pamplona
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Pozuelo De Alarcón, Madrid
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Sevilla
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Zaragoza
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Ávila
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Göteborg
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Stockholm
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Switzerland
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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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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/show/NCT01345669
Trial related presentations / publications
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/show/NCT01345669