{"preliminary_commentary":{"by_channel":{"x_thread":27,"youtube":22,"podcast":21,"bluesky_thread":5},"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\": \"NCT04619004\", \"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,"name":"HERTHENA-Lung01","nct_id":"NCT04619004","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=herthena-lung01-nct04619004. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Study Group 1 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)","label":"Study Group 1: Patritumab deruxtecan 5.6 mg/kg","type":"EXPERIMENTAL"},{"description":"Study Group 2 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan up-titration IV every 3 weeks (Q3W)","label":"Study Group 2: Patritumab deruxtecan Up-Titration","type":"EXPERIMENTAL"}],"collaborators":["Daiichi Sankyo Co., Ltd.","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-01-04","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer Metastatic","Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor"],"enrollment":{"count":277,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Patritumab Deruxtecan (Fixed dose)","otherNames":["U3-1402","HER3-DXd"],"type":"DRUG"},{"name":"Patritumab Deruxtecan (Up-Titration)","otherNames":["U3-1402","HER3-DXd"],"type":"DRUG"}],"last_update":"2026-09-01","lead_sponsor":"Daiichi Sankyo","official_title":"HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2022-11-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months"}],"references":[{"citation":"Yu HA, Goto Y, Janne PA. A study to learn how well HER3-DXd (patritumab deruxtecan) works and how safe it is in people with previously treated non-small-cell lung cancer that has a mutation in the EGFR gene: a plain language summary of the HERTHENA-Lung01 study. Future Oncol. 2026 Oct 12:1-16. doi: 10.1080/14796694.2026.2691681. Online ahead of print.","pmid":"42860885","type":"DERIVED"},{"citation":"Patel J, Meng J, Le H, Tanaka Y, Phani S, Salas M, Wu C, Sternberg D, Esker S, Anderson JP, Crowley A, Zhou SQ, Lieb C, Sun H, Doan QV, Santhanagopal A, Reckamp KL. Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy. Adv Ther. 2024 Aug;41(8):3299-3315. doi: 10.1007/s12325-024-02936-4. Epub 2024 Jul 3.","pmid":"38958845","type":"DERIVED"},{"citation":"Yu HA, Goto Y, Hayashi H, Felip E, Chih-Hsin Yang J, Reck M, Yoh K, Lee SH, Paz-Ares L, Besse B, Bironzo P, Kim DW, Johnson ML, Wu YL, John T, Kao S, Kozuki T, Massarelli E, Patel J, Smit E, Reckamp KL, Dong Q, Shrestha P, Fan PD, Patel P, Sporchia A, Sternberg DW, Sellami D, Janne PA. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. J Clin Oncol. 2023 Dec 10;41(35):5363-5375. doi: 10.1200/JCO.23.01476. Epub 2023 Sep 10.","pmid":"37689979","type":"DERIVED"},{"citation":"Yu HA, Yang JC, Hayashi H, Goto Y, Felip E, Reck M, Vigliotti M, Dong Q, Cantero F, Fan PD, Kanai M, Sternberg DW, Janne PA. HERTHENA-Lung01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated metastatic EGFR-mutated NSCLC. Future Oncol. 2023 Jun;19(19):1319-1329. doi: 10.2217/fon-2022-1250. Epub 2023 May 22.","pmid":"37212796","type":"DERIVED"}],"start_date":{"date":"2021-02-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04619004"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/herthena-lung01-nct04619004"}