{"preliminary_commentary":{"by_channel":{"x_thread":18,"youtube":2,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04358237\", \"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."},"name":"LUPER","nct_id":"NCT04358237","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=luper-nct04358237. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"LUPER","arms":[{"description":"During the phase I stage, patients will start receiving pembrolizumab at a fixed dose of 200 mg as a 30-min intravenous (IV) infusion followed by lurbinectedin at a starting dose of 2.4 mg/m2 as a 1-h IV infusion on Day 1, both every 3 weeks (Q3W). Lurbinectedin dose will be escalated from the starting dose in successive cohorts of patients, with a pre-established fixed dose increase (in mg/m2) of approximately 30%.\n\nDuring the phase II stage, patients will receive pembrolizumab at a fixed dose of 200 mg as a 30-min IV infusion followed by lurbinectedin as a 1-h IV infusion on Day 1 Q3W at the redommended dose (RD) determined during the phase I stage. A cycle is defined as an interval of 3 weeks. No dose escalation will be allowed during the phase II stage.","label":"Experimental: lurbinectedin (PM01183) + pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["MedSIR","PharmaMar","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2025-05-20","type":"ACTUAL"},"conditions":["Small Cell Lung Carcinoma"],"enrollment":{"count":28,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Lurbinectedin","otherNames":["PM01183","Zepsyre"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["Keytruda"],"type":"DRUG"}],"last_update":"2025-06-04","lead_sponsor":"Antonio Calles Blanco","official_title":"Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Pembrolizumab in Patients With Relapsed Small Cell Lung Cancer","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-09-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase I: Maximum tolerated dose (MTD) and recommended phase II dose (RD) of lurbinectedin in combination with pembrolizumab in patients with relapsed SCLC.","timeFrame":"12 months"},{"measure":"Phase II: Efficacy of lurbinectedin in combination with pembrolizumab in terms of overall response rate (ORR), according to RECIST 1.1, in patients with relapsed SCLC.","timeFrame":"38 months"}],"references":[{"citation":"Calles A, Navarro A, Doger de Speville Uribe BG, Colome EA, de Miguel M, Alvarez R, Arregui M, Moreno V, Rocha P, Calvo E, Ramon-Patino J, Corral de la Fuente E, Alcala-Lopez D, Boix O, Fernandez-Pinto M, Rodriguez-Morato J, Palmero R, Nadal E, Jove M, Felip E. Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study. J Thorac Oncol. 2025 Jul;20(7):969-982. doi: 10.1016/j.jtho.2025.02.005. Epub 2025 Feb 10.","pmid":"39938593","type":"DERIVED"}],"start_date":{"date":"2020-09-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.","url":"https://clinicaltrials.gov/study/NCT04358237"},"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/luper-nct04358237"}