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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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0
2011-000392-14
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Secondary ID [2]
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1200.131
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms
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0
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Condition category
Condition code
Cancer
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0
0
0
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease Free Survival (DFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Disease Free Survival (DFS) Rate at 2 Years
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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Percentage of Patient Deaths (Overall Survival (OS))
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Patients With Improved Health Related Quality of Life (HRQOL)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Time to Deterioration in Health Related Quality of Life (HRQOL)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Health Related Quality of Life (HRQOL) Scores Over Time
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/10/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/09/2016
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Sample size
Target
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Accrual to date
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Final
617
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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1200.131.06151 Boehringer Ingelheim Investigational Site - Wooloongabba
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Recruitment postcode(s) [1]
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- Wooloongabba
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Recruitment outside Australia
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Switzerland
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State/province [131]
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Bern
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Country [132]
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Ukraine
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State/province [132]
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Kharkiv
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Country [133]
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Ukraine
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State/province [133]
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Kiev
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Country [134]
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United Kingdom
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State/province [134]
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Denbighshire
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Country [135]
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United Kingdom
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State/province [135]
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Edinburgh
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Country [136]
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United Kingdom
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State/province [136]
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Exeter
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Country [137]
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United Kingdom
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State/province [137]
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Glasgow
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Country [138]
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United Kingdom
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State/province [138]
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Leicester
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Country [139]
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United Kingdom
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State/province [139]
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London
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Country [140]
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United Kingdom
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State/province [140]
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Manchester
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Country [141]
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United Kingdom
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State/province [141]
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Sheffield
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Country [142]
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United Kingdom
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State/province [142]
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Sutton
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Country [143]
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United Kingdom
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State/province [143]
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Whitchurch, Cardiff
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01345669
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01345669
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