LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Phase 3

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Afatinib (BIBW2992)	Afatinib	Once daily
Placebo	Placebo	Once daily

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	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

Name	Time	Method
Health Related Quality of Life (HRQOL)	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
Disease Free Survival (DFS) Rate at 2 Years	up to 2 years	Disease Free Survival (DFS) rate at 2 years is presented
Overall Survival (OS)	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.

Locations (16): 1200.162.86013 Boehringer Ingelheim Investigational Site
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Jinan, China
1200.162.86007 Boehringer Ingelheim Investigational Site
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Chengdu, China
1200.162.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1200.162.82002 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
1200.162.88603 Boehringer Ingelheim Investigational Site
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Keelung City, Taiwan
1200.162.86010 Boehringer Ingelheim Investigational Site
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Beijing, China
1200.162.86017 Boehringer Ingelheim Investigational Site
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Fuzhou, China
1200.162.86014 Boehringer Ingelheim Investigational Site
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Nanning, China
1200.162.86020 Boehringer Ingelheim Investigational Site
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Tianjin, China
1200.162.86012 Boehringer Ingelheim Investigational Site
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Beijing, China
1200.162.86019 Boehringer Ingelheim Investigational Site
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Changchun, China
1200.162.86005 Boehringer Ingelheim Investigational Site
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Guangzhou, China
1200.162.86003 Boehringer Ingelheim Investigational Site
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Hangzhou, China
1200.162.86001 Boehringer Ingelheim Investigational Site
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Shanghai, China
1200.162.86004 Boehringer Ingelheim Investigational Site
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Wuhan, China
1200.162.86018 Boehringer Ingelheim Investigational Site
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Wuhan, China