Trials / Terminated
TerminatedNCT01345669
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 617 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Once daily |
| DRUG | Afatinib | Once daily |
Timeline
- Start date
- 2011-10-17
- Primary completion
- 2016-09-12
- Completion
- 2016-09-12
- First posted
- 2011-05-02
- Last updated
- 2017-12-07
- Results posted
- 2017-10-23
Locations
162 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01345669. Inclusion in this directory is not an endorsement.