{"preliminary_commentary":{"by_channel":{"x_thread":11,"podcast":2,"youtube":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\": \"NCT04063163\", \"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":"ASTRUM-005","nct_id":"NCT04063163","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=astrum-005-nct04063163. 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":null,"arms":[{"description":"HLX 10+chemotherapy (Carboplatin-Etoposide)","label":"A","type":"EXPERIMENTAL"},{"description":"Placebo+chemotherapy (Carboplatin-Etoposide)","label":"B","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-05-07","type":"ACTUAL"},"conditions":["Extensive Stage Small Cell Lung Cancer"],"enrollment":{"count":585,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"HLX10","otherNames":[],"type":"DRUG"},{"name":"carboplatin and etoposide","otherNames":[],"type":"DRUG"},{"name":"placebo","otherNames":[],"type":"DRUG"}],"last_update":"2025-12-09","lead_sponsor":"Shanghai Henlius Biotech","official_title":"A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-05-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"OS","timeFrame":"The period from randomization through death regardless of causality (up to approximately 56 months)"}],"references":[{"citation":"Liu J, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Shi J, Pan Z, Shi J, Wang X, Bai Y, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Yu H, Li J, Yang X, Wang Q, Zhu J; ASTRUM-005 Study Group. First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 4:e261645. doi: 10.1001/jamaoncol.2026.1645. Online ahead of print.","pmid":"42240984","type":"DERIVED"},{"citation":"Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.","pmid":"40932107","type":"DERIVED"},{"citation":"Zhu Y, Liu K, Qin Q, Zhu H. Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4;13:1044678. doi: 10.3389/fimmu.2022.1044678. eCollection 2022.","pmid":"36685541","type":"DERIVED"},{"citation":"Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.","pmid":"36166026","type":"DERIVED"}],"start_date":{"date":"2019-09-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC","url":"https://clinicaltrials.gov/study/NCT04063163"},"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/astrum-005-nct04063163"}