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LUX-Head&Neck 2: A Phase III Trial of 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:
ClinicalTrials.gov Identifier:
NCT01345669
First Posted: May 2, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
April 28, 2011
May 2, 2011
October 12, 2017
October 2011
November 2018   (Final data collection date for primary outcome measure)
Disease Free Survival (DFS) [ Time Frame: Approximately 5 years ]
Same as current
Complete list of historical versions of study NCT01345669 on ClinicalTrials.gov Archive Site
  • Disease Free Survival (DFS) rate at 2 years [ Time Frame: 2 years ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ]
  • Changes in safety laboratory parameters [ Time Frame: Approximately 5 years ]
  • DFS rate at 2 years [ Time Frame: Approximately 5 years ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ]
  • Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ]
Not Provided
Not Provided
 
LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Head and Neck Neoplasms
  • Drug: Placebo
    Once daily
  • Drug: Afatinib
    Once daily
  • Experimental: Afatinib (BIBW 2992)
    Once daily
    Intervention: Drug: Afatinib
  • Placebo Comparator: Placebo
    Once daily
    Intervention: Drug: Placebo
Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
616
November 2018
November 2018   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
  2. Unresected tumour prior to chemo-radiotherapy (CRT)
  3. Concomitant CRT completed prior to randomisation
  4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  2. 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
  3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
  4. Known pre-existing Interstitial Lung Disease (ILD)
  5. Pregnancy or breast feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Mexico,   Netherlands,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Poland
 
NCT01345669
1200.131
2011-000392-14 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP