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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131155
• Other study ID #: 1200.162
• Status: Terminated
• Phase: Phase 3
• Start date: July 17, 2014
• Est. completion date: August 22, 2016

Study information

• Verified date: October 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 22, 2016
• Est. primary completion date: August 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Placebo
Once daily
• Afatinib
Once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	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.	up to 4 years
Secondary	Disease Free Survival (DFS) Rate at 2 Years	Disease Free Survival (DFS) rate at 2 years is presented	up to 2 years
Secondary	Overall Survival (OS)	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.	up to 4 years
Secondary	Health Related Quality of Life (HRQOL)	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	up to 4 years

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