At a glance
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A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 3 clinical trial evaluating Lapatinib, Chemoradiation, and 1 other intervention for Neoplasms, Head and Neck. Completed, enrolled 688 participants across 117 sites in 22 countries.
Detailed Summary
This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.
Study Details
Timeline
Interventions
Dual ErbB1/2 inhibitor
Radiation plus platinum based chemotherapy
Placebo