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A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Trial Profile

A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Serplulimab (Primary) ; Carboplatin; Etoposide
  • Indications Small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTRUM-005
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 24 Jun 2025 According to a Accord Healthcare media release, company has announced that Serplulimab has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body. This approval was based on the results of the global phase 3 clinical study ASTRUM-005.
  • 13 Jun 2025 According to Henlius Biopharmaceuticals media release, based upon this study HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe) has secured approvals in Singapore and Malaysia through its local license holder, KGbio (a subsidiary of PT Kalbe Farma Tbk.), under the trade name Zerpidio for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
  • 04 Jun 2025 According to a Shanghai Henlius Biotech media release, Ying Cheng is the lead investigator of the study.

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