NCT02131155

LUX-Head & Neck 4: 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: 36 (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

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Placebo	Once daily
DRUG	Afatinib	Once daily

Timeline

• Start date: 2014-07-17
• Primary completion: 2016-08-22
• Completion: 2016-08-22
• First posted: 2014-05-06
• Last updated: 2019-03-01
• Results posted: 2019-03-01

Locations

17 sites across 4 countries: China, Singapore, South Korea, Taiwan