{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03260491","nct_id":"NCT03260491","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03260491. 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":"Participants in the Dose Escalation Cohort 1 will receive HER3-DXd intravenously (IV) once every three weeks at 3.2 mg/kg.","label":"Dose Escalation: Cohort 1, 3.2 mg/kg","type":"EXPERIMENTAL"},{"description":"Participants in Dose Escalation Cohort 2 will receive HER3-DXd intravenously (IV) once every three weeks at 4.8 mg/kg.","label":"Dose Escalation: Cohort 2, 4.8 mg/kg","type":"EXPERIMENTAL"},{"description":"Participants in Dose Escalation Cohort 3 will receive HER3-DXd intravenously (IV) once every three weeks at 5.6 mg/kg.","label":"Dose Escalation: Cohort 3, 5.6 mg/kg","type":"EXPERIMENTAL"},{"description":"Participants in Dose Escalation Cohort 3 will receive HER3-DXd intravenously (IV) once every three weeks at 6.4 mg/kg.","label":"Dose Escalation: Cohort 4, 6.4 mg/kg","type":"EXPERIMENTAL"},{"description":"Participants with adenocarcinoma NSCLC with EGFR mutations in the Dose Expansion Cohort 1 will receive HER3-DXd IV once every three weeks at the established recommended dose for expansion (RDE).","label":"Dose Expansion: Cohort 1, EGFR mutant","type":"EXPERIMENTAL"},{"description":"Participants with squamous or non-squamous NSCLC without EGFR-activating mutations in the Dose Expansion Cohort 2 will receive HER3-DXd IV once every three weeks at the established recommended dose for expansion (RDE).","label":"Dose Expansion: Cohort 2, EGFR wild-type","type":"EXPERIMENTAL"},{"description":"Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3a will receive HER3-DXd IV once every three weeks at the established recommended dose for expansion (RDE) or, if applicable, adjusted RDE (aRDE).","label":"Dose Expansion: Cohort 3a, EGFR mutant","type":"EXPERIMENTAL"},{"description":"Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3b will receive HER3-DXd IV once every three weeks following an up-titration regimen (Cycle 1, Day 1: 57% of RDE or aRDE; Cycle 2, Day 1: 86% of RDE or, if applicable aRDE; Cycle 3 and subsequent cycles, Day 1: 114% of RDE or aRDE).","label":"Dose Expansion: Cohort 3b, EGFR mutant","type":"EXPERIMENTAL"},{"description":"Participants with NSCLC (including any histology other than small-cell or combined small-cell and non-small cell) with an EGFR-activating mutation will receive HER3-DXd IV at 5.6 mg/kg every 3 weeks.","label":"Dose Expansion: Cohort 4, EGFR mutant","type":"EXPERIMENTAL"},{"description":"Participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation and that have progressed on the most recent line of therapy will receive HER3-DXd IV at 5.6 mg/kg every 3 weeks.","label":"Dose Expansion: Cohort 5, KRAS-G12C mutant NSCLC","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-07-30","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":{"count":312,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HER3-DXd (FL-DP)","otherNames":["U3-1402"],"type":"DRUG"},{"name":"HER3-DXd (CTM-1 Lyo-DP)","otherNames":["U3-1402"],"type":"DRUG"},{"name":"HER3-DXd (CTM-3 Lyo-DP)","otherNames":["U3-1402"],"type":"DRUG"}],"last_update":"2026-10-26","lead_sponsor":"Daiichi Sankyo","official_title":"A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2025-12-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Dose-limiting toxicities (DLTs) during dose escalation","timeFrame":"21 days of Cycle 1"},{"measure":"Summary of adverse events during dose escalation","timeFrame":"By the global end of trial date, approximately within 36 months"},{"measure":"Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion (Dose Expansion Cohorts 1, 2, 3a, 3b, and Cohort 5)","timeFrame":"Approximately within 36 months"},{"measure":"Maximum serum concentration (Cmax) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)","timeFrame":"During the first 5 cycles (each cycle is 21 days), including an intensive sampling schedule: pre-dose, end of infusion (EOI), 2 hour (hr), 4 hr, 8 hr post infusion, Day 8, and Day 15."},{"measure":"Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)","timeFrame":"During the first 5 cycles (each cycle is 21 days), including an intensive sampling schedule: pre-dose, end of infusion (EOI), 2 hour (hr), 4 hr, 8 hr post infusion, Day 8, and Day 15."}],"references":[{"citation":"Jackman D, Pao W, Riely GJ, Engelman JA, Kris MG, Janne PA, Lynch T, Johnson BE, Miller VA. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol. 2010 Jan 10;28(2):357-60. doi: 10.1200/JCO.2009.24.7049. Epub 2009 Nov 30.","pmid":"19949011","type":"BACKGROUND"},{"citation":"Steuer CE, Hayashi H, Su WC, Nishio M, Johnson ML, Kim DW, Massarelli E, Felip E, Gold KA, Murakami H, Baik CS, Kim SW, Smit EF, Fujimura M, Fan PD, Truchon K, Su X, Sternberg DW, Janne PA. Patritumab Deruxtecan (HER3-DXd; MK-1022) in Non-Small Cell Lung Cancer After Platinum-Based Chemotherapy and Immunotherapy. J Clin Oncol. 2025 Sep;43(25):2816-2826. doi: 10.1200/JCO-24-02744. Epub 2025 Jun 24.","pmid":"40554742","type":"DERIVED"}],"start_date":{"date":"2017-10-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT03260491"},"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/nct03260491"}