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

> **NCT03258554** · PHASE2,PHASE3 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 196 (actual)

## Conditions studied

- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Head and Neck Squamous Cell Carcinoma
- Hypopharyngeal Squamous Cell Carcinoma
- Laryngeal Squamous Cell Carcinoma
- Oral Cavity Squamous Cell Carcinoma
- Oropharyngeal Squamous Cell Carcinoma
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Squamous Cell Carcinoma of Unknown Primary
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

## Interventions

- **BIOLOGICAL:** Cetuximab
- **BIOLOGICAL:** Durvalumab
- **RADIATION:** Intensity-Modulated Radiation Therapy
- **OTHER:** Laboratory Biomarker Analysis
- **OTHER:** Quality-of-Life Assessment
- **OTHER:** Questionnaire Administration

## Key facts

- **NCT ID:** NCT03258554
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-04-03
- **Primary completion:** 2022-09-20
- **Final completion:** 2025-09-04
- **Target enrollment:** 196 (ACTUAL)
- **Last updated:** 2026-02-06

## Collaborators

- Canadian Cancer Trials Group
- NRG Oncology

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03258554

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03258554, "Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin". Retrieved via AI Analytics 2026-05-18 from https://api.ai-analytics.org/clinical/NCT03258554. Licensed CC0.

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