{"preliminary_commentary":{"by_channel":{"x_thread":7,"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05631262\", \"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":[["sacituzumab tirumotecan"]],"indication":"advanced solid tumors","name":"OptiTROP-Lung03","nct_id":"NCT05631262","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=optitrop-lung03-nct05631262. 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":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"SKB264 (Cohort 1)","type":"EXPERIMENTAL"},{"description":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"SKB264 (Cohort 2)","type":"EXPERIMENTAL"},{"description":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"SKB264 (Cohort 3)","type":"EXPERIMENTAL"},{"description":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"SKB264 (Cohort 4)","type":"EXPERIMENTAL"},{"description":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"SKB264 (Cohort 5)","type":"EXPERIMENTAL"},{"description":"SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle","label":"Part II Test group","type":"EXPERIMENTAL"},{"description":"Docetaxel will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle","label":"Part II Control group","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-12-30","type":"ESTIMATED"},"conditions":["Selected Subjects With Advanced Solid Tumors"],"enrollment":{"count":321,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"SKB264","otherNames":[],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"}],"last_update":"2026-05-08","lead_sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","official_title":"A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-12-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR)","timeFrame":"From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months."},{"measure":"Incidence and severity of adverse events (AEs)","timeFrame":"From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment."}],"references":[{"citation":"Fang W, Li X, Wang Q, Meng X, Zheng W, Sun L, Yao W, Zhuang W, Fan Y, Zhuo M, Luo Y, Zhang Z, Song X, Yang R, Yang J, Jin X, Diao Y, Ge J, Zhang L. Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial. BMJ. 2025 Jun 5;389:e085680. doi: 10.1136/bmj-2025-085680.","pmid":"40473437","type":"DERIVED"},{"citation":"Zhao S, Cheng Y, Wang Q, Li X, Liao J, Rodon J, Meng X, Luo Y, Chen Z, Wang W, Yi T, Li Y, Yin Y, Xu H, Yu G, Mi Y, Fan Y, Wainberg ZA, Wang X, Su C, Yu Q, Lai S, Sun L, Zhuang W, Wang X, Yang J, Li Y, Ge J, Li J, Zhang L, Fang W. Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: phase 1/2 and phase 2 trials. Nat Med. 2025 Jun;31(6):1976-1986. doi: 10.1038/s41591-025-03638-2. Epub 2025 Apr 10.","pmid":"40210967","type":"DERIVED"}],"start_date":{"date":"2022-11-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT05631262"},"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/optitrop-lung03-nct05631262"}