Clinical trial NCT02131155: LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: up to 4 years
Secondary outcomes:
measure: Disease Free Survival (DFS) Rate at 2 Years
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 4 years
measure: Health Related Quality of Life (HRQOL)
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1200.162.86010 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1200.162.86012 Boehringer Ingelheim Investigational Site
city: Changchun
country: China
facility: 1200.162.86019 Boehringer Ingelheim Investigational Site
city: Chengdu
country: China
facility: 1200.162.86007 Boehringer Ingelheim Investigational Site
city: Fuzhou
country: China
facility: 1200.162.86017 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1200.162.86005 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1200.162.86003 Boehringer Ingelheim Investigational Site
city: Jinan
country: China
facility: 1200.162.86013 Boehringer Ingelheim Investigational Site
city: Nanning
country: China
facility: 1200.162.86014 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1200.162.86001 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 1200.162.86020 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1200.162.86004 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1200.162.86018 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.162.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.162.82002 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
city: Keelung City
country: Taiwan
facility: 1200.162.88603 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: