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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02131155
First received: May 5, 2014
Last updated: December 14, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Head and Neck Neoplasms
Drug: Placebo
Drug: Afatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: up to 4 years ]

Secondary Outcome Measures:
  • Disease Free Survival (DFS) rate at 2 years [ Time Frame: up to 4 years ]
  • Overall Survival (OS) [ Time Frame: up to 4 years ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: up to 4 years ]

Enrollment: 36
Study Start Date: July 2014
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib (BIBW2992)
Once daily
Drug: Afatinib
Once daily
Placebo Comparator: Placebo
Once daily
Drug: Placebo
Once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131155

Locations
China
Boehringer Ingelheim Investigational Site
Beijing, China
Boehringer Ingelheim Investigational Site
Changchun, China
Boehringer Ingelheim Investigational Site
Chengdu, China
Boehringer Ingelheim Investigational Site
Fuzhou, China
Boehringer Ingelheim Investigational Site
Guangzhou, China
Boehringer Ingelheim Investigational Site
Hangzhou, China
Boehringer Ingelheim Investigational Site
Jinan, China
Boehringer Ingelheim Investigational Site
Nanning, China
Boehringer Ingelheim Investigational Site
Shanghai, China
Boehringer Ingelheim Investigational Site
Tianjin, China
Boehringer Ingelheim Investigational Site
Wuhan, China
Korea, Republic of
Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Singapore
Boehringer Ingelheim Investigational Site
Singapore, Singapore
Taiwan
Boehringer Ingelheim Investigational Site
Keelung City, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02131155     History of Changes
Other Study ID Numbers: 1200.162
Study First Received: May 5, 2014
Last Updated: December 14, 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 26, 2017