LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention
Name: Placebo Type: Drug
Name: Afatinib Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
1200.162.86002 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Not yet recruiting
1200.162.86010 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.162.86011 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.162.86012 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.162.86021 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.162.86019 Boehringer Ingelheim Investigational Site
Changchun, China
Status: Recruiting
1200.162.86007 Boehringer Ingelheim Investigational Site
Chengdu, China
Status: Recruiting
1200.162.86008 Boehringer Ingelheim Investigational Site
Chengdu, China
Status: Recruiting
1200.162.86017 Boehringer Ingelheim Investigational Site
Fuzhou, China
Status: Recruiting
1200.162.86003 Boehringer Ingelheim Investigational Site
Hangzhou, China
Status: Recruiting
1200.162.86013 Boehringer Ingelheim Investigational Site
Jinan, China
Status: Recruiting
1200.162.86016 Boehringer Ingelheim Investigational Site
Kunming, China
Status: Recruiting
1200.162.86014 Boehringer Ingelheim Investigational Site
Nanning, China
Status: Recruiting
1200.162.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.162.86006 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.162.86009 Boehringer Ingelheim Investigational Site
Shenyang, China
Status: Recruiting
1200.162.86020 Boehringer Ingelheim Investigational Site
Tianjin, China
Status: Recruiting
1200.162.86004 Boehringer Ingelheim Investigational Site
Wuhan, China
Status: Recruiting
1200.162.86018 Boehringer Ingelheim Investigational Site
Wuhan, China
Status: Recruiting
1200.162.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.162.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.162.65001 Boehringer Ingelheim Investigational Site
Singapore, Singapore
Status: Recruiting
1200.162.88602 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Status: Recruiting
1200.162.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Status: Recruiting
Start Date
July 2014
Completion Date
August 2020
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page