Phase III International Study Comparing Radiotherapy With or Without Nimotuzumab in Adults with Locoregionally Advanced Head and Neck Squamous Cell Carcinoma Who Cannot Receive Platinum-Based Chemotherapy

What this Trial Is About

Researchers are evaluating treatments for patients with locoregionally advanced head and neck squamous cell carcinoma LA-HNSCC who cannot receive platinum-based chemotherapy. This international, open-label, randomized Phase III study compares radiotherapy combined with nimotuzumab to radiotherapy alone. The goal is to assess the safety and effectiveness of adding nimotuzumab to radiotherapy in this specific group of patients. Participants receive radiotherapy using an intensity-modulated technique, either photon IMRT or proton IMPT, delivering a total dose of 70 Gy over 35 fractions, five times a week. In one group, nimotuzumab is given as a 200 mg intravenous injection once weekly for seven weeks during radiotherapy. The other group receives only the radiotherapy treatment. This study is conducted across about 70 sites worldwide. During the study, participants will be followed for at least 24 months after treatment starts. Researchers will monitor progression-free survival as the primary outcome. Secondary outcomes include locoregional control, distant metastasis rate, overall survival, tumor response, and quality of life. Participants will undergo evaluations and assessments throughout the study to track these outcomes and any safety concerns.

Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma