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

Arms (2)

1. type

   EXPERIMENTAL

   label

   Afatinib (BIBW2992)

   description

   Once daily

   interventionNames

   1. Drug: Afatinib

2. type

   PLACEBO_COMPARATOR

   label

   Placebo

   description

   Once daily

   interventionNames

   1. Drug: Placebo

Primary outcomes (1)

1. measure

   Disease Free Survival (DFS)

   timeFrame

   up to 4 years

   description

   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.