1200.131 LUX-Head & Neck 2; Afatinib in Squamous Cell Carcinoma
Research type
Research Study
Full title
LUX-Head & Neck 2; 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
IRAS ID
75223
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2011-000392-14
ISRCTN Number
not known
Research summary
This study is a phase III, randomised, double-blind trial, to investigate whether afatinib is better than placebo in preventing or delaying the return of cancer after chemo-radiotherapy. The study will be conducted in patients who have completed initial chemo-radiotherapy treatment for locally advanced head and neck squamous cell cancer and who have no evidence of cancer remaining.Patients will undergo screening assessments to confirm their eligibility to participate. Eligible patients will then be randomised to receive daily tablets containing either afatinib or matching placebo for 80 weeks. Tablets will stop earlier if there are undue side effects or if the tumour returns. Patients will attend the clinic after one week, two weeks and four weeks of treatment and then every four weeks for the rest of the treatment period. After taking the last tablet, patients will have a follow-up visit after four weeks, then further follow-up visits every 16 weeks until week 112 and then every 24 weeks until the end of the study. If the tumour returns, then the patient will no longer be in the study, but information on further treatment and long-term outcome will be collected if available.In addition to investigating the efficacy of afatinib, the study will also look at the safety of afatinib and the effects of treatment on quality of life.
REC name
London - Chelsea Research Ethics Committee
REC reference
11/LO/0954
Date of REC Opinion
19 Jul 2011
REC opinion
Favourable Opinion