{"preliminary_commentary":{"by_channel":{"x_thread":12,"youtube":10,"podcast":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\": \"NCT05218499\", \"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":"Brightline-1","nct_id":"NCT05218499","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=brightline-1-nct05218499. 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":"Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).","label":"Brigimadlin 30 mg q3w","type":"EXPERIMENTAL"},{"description":"Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).","label":"Brigimadlin 45 mg q3w","type":"EXPERIMENTAL"},{"description":"Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).","label":"Doxorubicin","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-01-26","type":"ACTUAL"},"conditions":["Liposarcoma, Dedifferentiated"],"enrollment":{"count":400,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Brigimadlin","otherNames":["BI 907828"],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"}],"last_update":"2026-03-02","lead_sponsor":"Boehringer Ingelheim","official_title":"Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2024-04-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Up to 20.6 months."}],"references":[{"citation":"Schoffski P, Lahmar M, Lucarelli A, Maki RG. Brightline-1: phase II/III trial of the MDM2-p53 antagonist BI 907828 versus doxorubicin in patients with advanced DDLPS. Future Oncol. 2023 Mar;19(9):621-629. doi: 10.2217/fon-2022-1291. Epub 2023 Mar 29.","pmid":"36987836","type":"DERIVED"}],"start_date":{"date":"2022-03-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma","url":"https://clinicaltrials.gov/study/NCT05218499"},"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/brightline-1-nct05218499"}