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Clinical trial · no report yet · Phase 2/Phase 3
NRG-HN004
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
- NCT03258554 ↗
- Completed
- National Cancer Institute (NCI)
- Focused
We haven't built an HCP commentary report on NRG-HN004 (durvalumab in locoregionally advanced head and neck cancer, cisplatin contraindication) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NRG-HN004 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 10 |
The trial
ClinicalTrials.gov- Official title
- Randomized Phase II/III Trial of Radiotherapy With Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy With Concurrent Cetuximab in Patients With Locoregionally Advanced Head and Neck Cancer With a Contraindication to Cisplatin
- Phase
- Phase 2/Phase 3
- Status
- Completed
- Conditions
- 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
- Cetuximab; Durvalumab; Intensity-Modulated Radiation Therapy; Laboratory Biomarker Analysis; Quality-of-Life Assessment; Questionnaire Administration
- Arms
- Arm I (cetuximab, radiation therapy) · Active comparator
- Arm II (durvalumab, radiation therapy) · Experimental
- Enrollment
- 196
- Primary outcomes
- Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase]
- Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]
- Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary]
- Sponsor
- National Cancer Institute (NCI) with Canadian Cancer Trials Group, NRG Oncology
- Start
- Apr 3, 2018
- Primary completion
- Sep 20, 2022
- Results posted
- Yes
- Registry record
- NCT03258554 · updated Aug 27, 2026
Publications
linked from the registry- 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. PubMed 39551064