Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Summary

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

Timeline

Start

2018-04-03

Primary completion

2022-09-20

Completion

2025-09-04

Publications

• Mell LK, Torres-Saavedra PA, Wong SJ, Kish JA, Chang SS, Jordan RC, Liu T, Truong MT, Winquist EW, Takiar V, Wise-Draper T, Robbins JR, Rodriguez CP, Awan MJ, Beadle BM, Henson C, Narayan S, Spencer SA, Powell S, Dunlap N, Sacco AG, Hu KS, Park HS, Bauman JE, Harris J, Yom SS, Le QT. Radiotherapy with cetuximab or durvalumab for locoregionally advanced head and neck cancer in patients with a contraindication to cisplatin (NRG-HN004): an open-label, multicentre, parallel-group, randomised, phase 2/3 trial. Lancet Oncol. 2024 Dec;25(12):1576-1588. doi: 10.1016/S1470-2045(24)00507-2. Epub 2024 Nov 14.

Drugs

Indications