DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

Phase 3 Completed 619 enrolled Danish Head and Neck Cancer Group

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Timeline

Start: 2007-11
Primary completion: 2012-07
Completion: 2016-11

Outcome

Missed primary endpoint

paper The 5-year loco-regional failure rate was 24 % in the zalutumumab-arm and 18 % in the control-arm; Hazard Ratio (HR) 1.16 (95 % CI 0.84-1.59); PMID 40258418 ↗

paper Addition of concomitant zalutumumab to primary (chemo-)radiotherapy and concomitant nimorazole for HNSCC did not increase loco-regional control PMID 40258418 ↗

Publications

Eriksen JG, Maare C, Johansen J, Primdahl H, Bratland A, Kristensen CA, Andersen M, Alsner J, Overgaard J; DAHANCA. DAHANCA19: A randomized phase III study of primary curative (chemo)-radiotherapy and the EGFR-inhibitor zalutumumab for squamous cell carcinoma of the head and neck. Radiother Oncol. 2025 Jul;208:110899. doi: 10.1016/j.radonc.2025.110899. Epub 2025 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zalutumumab	Monoclonal antibody	8 mg/kg	—