LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01345682
First received: April 28, 2011
Last updated: July 23, 2014
Last verified: July 2014

April 28, 2011
July 23, 2014
January 2012
March 2014   (final data collection date for primary outcome measure)
The primary efficacy endpoint of the trial is progression free survival (PFS) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01345682 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) is the key secondary endpoint [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Objective response based on RECIST [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Health related quality of life (HRQOL) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Changes in safety laboratory parameters [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) is the key secondary endpoint [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Objective response based on RECIST [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Health related quality of life (HRQOL) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
  • Drug: Afatinib
    Once daily
  • Drug: Methotrexate
    Weekly
  • Experimental: Afatinib (BIBW 2992)
    Once daily
    Intervention: Drug: Afatinib
  • Active Comparator: Methotrexate
    Weekly
    Intervention: Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
474
July 2015
March 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
  3. Measurable disease according to RECIST
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
  2. Any other than one previous platinum based systemic regimen given for R/M disease
  3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
  4. Pregnancy or breast feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Belgium,   Brazil,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Mexico,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland
 
NCT01345682
1200.43, 2011-000391-34
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

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