Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
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.
Timeline
- Start
- 2006-12
- Primary completion
- 2013-03
- Completion
- 2013-11
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Lapatinib 1500 mg; p = 0.4502; Non-stratified log-rank test NCT00424255 ↗
registry Placebo vs Lapatinib 1500 mg; p = 0.4502; Non-stratified log-rank test NCT00424255 ↗
paper Median DFS assessed by an independent review committee was 53.6 months and not reached for lapatinib and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.85 to 1.43). PMID 26527790 ↗
Publications
- Sunkara PR, Chow E, Waitzman J, Sukari A, Cramer JD. The Prognostication of Surgically Resected Head and Neck Squamous Cell Carcinoma Using Pre-Therapy Neutrophil and Lymphocyte Counts. Head Neck. 2025 Feb;47(2):687-694. doi: 10.1002/hed.27949. Epub 2024 Oct 16.
- Sunkara PR, Graff JT, Cramer JD. Association of Surgical Margin Distance With Survival in Patients With Resected Head and Neck Squamous Cell Carcinoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Apr 1;149(4):317-326. doi: 10.1001/jamaoto.2022.5186.
- Harrington K, Temam S, Mehanna H, D'Cruz A, Jain M, D'Onofrio I, Manikhas G, Horvath Z, Sun Y, Dietzsch S, Dubinsky P, Holeckova P, El-Hariry I, Franklin N, Biswas-Baldwin N, Legenne P, Wissel P, Netherway T, Farrell J, Ellis C, Wang-Silvanto J, Amonkar M, Ahmed N, Santillana S, Bourhis J. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Oncol. 2015 Dec 10;33(35):4202-9. doi: 10.1200/JCO.2015.61.4370. Epub 2015 Nov 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | 1500 mg | Oral |