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 is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01345669
First received: April 28, 2011
Last updated: September 3, 2014
Last verified: September 2014

April 28, 2011
September 3, 2014
October 2011
August 2017   (final data collection date for primary outcome measure)
Disease Free Survival (DFS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Changes in safety laboratory parameters [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
  • DFS rate at 2 years [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
669
May 2019
August 2017   (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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT01345669
1200.131, 2011-000392-14
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

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