{"preliminary_commentary":{"by_channel":{"x_thread":10},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03258554\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["durvalumab"]],"indication":"locoregionally advanced head and neck cancer, cisplatin contraindication","name":"NRG-HN004","nct_id":"NCT03258554","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nrg-hn004-nct03258554. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive cetuximab IV weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo IMRT 5 fractions per week for up to 7 weeks.","label":"Arm I (cetuximab, radiation therapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.","label":"Arm II (durvalumab, radiation therapy)","type":"EXPERIMENTAL"}],"collaborators":["Canadian Cancer Trials Group","NRG Oncology"],"completion_date":{"date":"2025-09-04","type":"ACTUAL"},"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"],"enrollment":{"count":196,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cetuximab","otherNames":["C 225","C-225","C225","Cetuximab Biosimilar CDP-1","Cetuximab Biosimilar CMAB009","Cetuximab Biosimilar KL 140","Chimeric Anti-EGFR Monoclonal Antibody","Chimeric MoAb C225","Chimeric Monoclonal Antibody C225","Erbitux","IMC-C225"],"type":"BIOLOGICAL"},{"name":"Durvalumab","otherNames":["Imfinzi","Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer","MEDI 4736","MEDI-4736","MEDI4736"],"type":"BIOLOGICAL"},{"name":"Intensity-Modulated Radiation Therapy","otherNames":["IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy"],"type":"RADIATION"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"}],"last_update":"2026-08-27","lead_sponsor":"National Cancer Institute (NCI)","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","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2022-09-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase]","timeFrame":"From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT."},{"measure":"Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]","timeFrame":"From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years."},{"measure":"Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary]","timeFrame":"From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years."}],"references":[{"citation":"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.","pmid":"39551064","type":"DERIVED"}],"start_date":{"date":"2018-04-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin","url":"https://clinicaltrials.gov/study/NCT03258554"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nrg-hn004-nct03258554"}