{"preliminary_commentary":{"by_channel":{"x_thread":6,"podcast":1},"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,"name":"HORIZON-Lung","nct_id":"NCT04818333","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=horizon-lung-nct04818333. 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":"SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment","label":"SHR-A1811","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-06","type":"ESTIMATED"},"conditions":["Advanced Non-small Cell Lung Cancer"],"enrollment":{"count":157,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"SHR-A1811","otherNames":[],"type":"DRUG"}],"last_update":"2024-06-13","lead_sponsor":"Jiangsu HengRui Medicine Co., Ltd.","official_title":"Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation","overall_status":"UNKNOWN","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811","timeFrame":"From Day 1 to90 days after last dose ，appropriately to 3 years"},{"measure":"Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811","timeFrame":"From Day 1 to90 days after last dose ，appropriately to 3 years"},{"measure":"Phase1: Maximum tolerated dose (MTD)","timeFrame":"12 months"},{"measure":"Phase 1: Recommended Phase 2 dose (RP2D)","timeFrame":"12 months"},{"measure":"Phase2:ObjectiveResponse Rate (ORR)","timeFrame":"Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years"}],"references":[{"citation":"Li Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25.","pmid":"40020696","type":"DERIVED"},{"citation":"Li Z, Song Z, Hong W, Yang N, Wang Y, Jian H, Liang Z, Hu S, Peng M, Yu Y, Wang Y, Jiao Z, Zhao K, Song K, Li Y, Shi W, Lu S. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024 Jul 15;9(1):182. doi: 10.1038/s41392-024-01897-y.","pmid":"39004647","type":"DERIVED"}],"start_date":{"date":"2021-04-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04818333"},"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/horizon-lung-nct04818333"}