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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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ClinicalTrials.gov Identifier: NCT01345669
Recruitment Status : Terminated
First Posted : May 2, 2011
Results First Posted : October 23, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 28, 2011
First Posted Date  ICMJE May 2, 2011
Results First Submitted Date  ICMJE August 17, 2017
Results First Posted Date  ICMJE October 23, 2017
Last Update Posted Date December 7, 2017
Actual Study Start Date  ICMJE October 17, 2011
Actual Primary Completion Date September 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Disease Free Survival (DFS) [ Time Frame: Approximately 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • Disease Free Survival (DFS) Rate at 2 Years [ Time Frame: Up to 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.
  • Percentage of Patient Deaths (Overall Survival (OS)) [ Time Frame: Up to 5 years ]
    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.
  • Patients With Improved Health Related Quality of Life (HRQOL) [ Time Frame: Up to 5 years ]
    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.
  • Time to Deterioration in Health Related Quality of Life (HRQOL) [ Time Frame: Up to 5 years ]
    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.
  • Health Related Quality of Life (HRQOL) Scores Over Time [ Time Frame: Baseline and 5 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
  • Changes in safety laboratory parameters [ Time Frame: Approximately 5 years ]
  • DFS rate at 2 years [ Time Frame: Approximately 5 years ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ]
  • Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Neoplasms
Intervention  ICMJE
  • Drug: Placebo
    Once daily
  • Drug: Afatinib
    Once daily
Study Arms  ICMJE
  • Experimental: Afatinib (BIBW 2992)
    Once daily
    Intervention: Drug: Afatinib
  • Placebo Comparator: Placebo
    Once daily
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 21, 2017)
617
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2011)
669
Actual Study Completion Date  ICMJE September 12, 2016
Actual Primary Completion Date September 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Mexico,   Netherlands,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01345669
Other Study ID Numbers  ICMJE 1200.131
2011-000392-14 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP