BI-1200.43

Study Sponsor: Boehringer Ingelheim

Study Title

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

Medicine or Vaccine (generic name)

afatinib

Sponsor Identification Number

1200.43

Trial Registry Identification Number(#'s)

NCT01345682

Medical Condition

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Phase

Phase 3

Link to study details on the BI Clinical Study Register

http://trials.boehringer-ingelheim.com/trial_results/clinical_trials_overview.html

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT01345682?term=1200.43&rank=1

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

October 2015