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LUX-Head & Neck 4: 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: NCT02131155
Recruitment Status : Terminated
First Posted : May 6, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Placebo Drug: Afatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 17, 2014
Actual Primary Completion Date : August 22, 2016
Actual Study Completion Date : August 22, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Afatinib (BIBW2992)
Once daily
Drug: Afatinib
Once daily

Placebo Comparator: Placebo
Once daily
Drug: Placebo
Once daily




Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: up to 4 years ]

    DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first.

    For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e.

    DFS [day] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1.

    For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive:

    DFS (censored) [days] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.



Secondary Outcome Measures :
  1. Disease Free Survival (DFS) Rate at 2 Years [ Time Frame: up to 2 years ]
    Disease Free Survival (DFS) rate at 2 years is presented

  2. Overall Survival (OS) [ Time Frame: up to 4 years ]

    OS was defined as time from the date of randomisation until death.

    For patients with known date of death (regardless of the cause of death):

    OS [days] = date of death - date of randomisation +1

    For patients known to be alive by the end of trial:

    OS (censored) [days] = the last date when the patient was known to be alive - date of randomisation +1 OS was to be analysed similarly to DFS.


  3. Health Related Quality of Life (HRQOL) [ Time Frame: up to 4 years ]

    The main analysis of HRQOL questionnaires was to focus on the change in score from baseline in the following scales measured on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-H&N35:

    • Global Health Status/ Quality of Life (QOL) Scale
    • Pain Scale
    • Swallowing Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • Cancer of nasopharynx, sinuses, and/or salivary glands
  • Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  • Known pre-existing Interstitial Lung Disease (ILD)
  • Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131155


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02131155    
Other Study ID Numbers: 1200.162
First Posted: May 6, 2014    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action