{"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":[["patritumab deruxtecan","osimertinib"],["patritumab deruxtecan"]],"indication":"locally advanced or metastatic EGFR-mutated NSCLC","name":"NCT04676477","nct_id":"NCT04676477","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04676477. 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 phase will receive HER3-DXd IV Q3W + osimertinib PO once daily. The dose of HER3-DXd in the first cohort will be 3.2 mg/kg Q3W. The dose of osimertinib in the first cohort will be 80 mg PO once daily.","label":"Dose Escalation: HER3-DXd + osimertinib","type":"EXPERIMENTAL"},{"description":"Participants in the Second-line Dose Expansion phase will be randomized to receive HER3-DXd + osimertinib at the RCD","label":"Second-line Dose Expansion: HER3-DXd + osimertinib (RCD)","type":"EXPERIMENTAL"},{"description":"Participants in the Second-line Dose Expansion phase will be randomized to receive HER3-DXd 5.6 mg/kg IV Q3W","label":"Second-line Dose Expansion: HER3-DXd","type":"EXPERIMENTAL"},{"description":"If the RCD includes an osimertinib dose of 80 mg PO once daily, then participants will receive treatment with HER3-DXd and osimertinib at the RCD","label":"First-line Dose Expansion: HER3-DXd + osimertinib (Cohort 3; RCD)","type":"EXPERIMENTAL"},{"description":"Participants in the First-line Dose Expansion phase will be randomized to receive HER3-DXd 5.6 mg/kg IV Q3W and osimertinib dose of 80 mg PO once daily.","label":"First-line Dose Expansion: HER3-DXd + osimertinib (Cohort 4a)","type":"EXPERIMENTAL"},{"description":"Participants in the First-line Dose Expansion phase will be randomized to receive HER3-DXd 4.8 mg/kg IV Q3W and osimertinib dose of 80 mg PO once daily.","label":"First-line Dose Expansion: HER3-DXd + osimertinib (Cohort 4b)","type":"EXPERIMENTAL"}],"collaborators":["AstraZeneca","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-12-14","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":{"count":246,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HER3-DXd","otherNames":["U3-1402","Patritumab deruxtecan"],"type":"DRUG"},{"name":"HER3-DXd","otherNames":["U3-1402","Patritumab deruxtecan"],"type":"DRUG"},{"name":"Osimertinib","otherNames":[],"type":"DRUG"},{"name":"Osimertinib","otherNames":[],"type":"DRUG"},{"name":"HER3-DXd","otherNames":["U3-1402","Patritumab deruxtecan"],"type":"DRUG"},{"name":"HER3-DXd","otherNames":["U3-1402","Patritumab deruxtecan"],"type":"DRUG"},{"name":"Osimertinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-26","lead_sponsor":"Daiichi Sankyo","official_title":"A Phase 1 Open-Label Study of HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2025-01-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)","timeFrame":"From signing of informed consent form up to 40 days (+7 days) after the last dose of study drugs, up to approximately 9 months"},{"measure":"Second-line Dose Expansion and First-line Dose Expansion: Objective Response Rate (ORR)","timeFrame":"From start of study treatment until date of documented disease progression or other protocol-defined reason for discontinuation from the study (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 18 months"}],"references":[],"start_date":{"date":"2021-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04676477"},"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/nct04676477"}