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A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

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Trial Profile

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Feb 2024

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At a glance

  • Drugs Carboplatin (Primary) ; HLX 26 (Primary) ; Paclitaxel (Primary) ; Pemetrexed (Primary) ; Serplulimab (Primary)
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 21 Feb 2024 Interventional study model changed to parallel from sequential, this study is now an double blind and randomized study, number of treatment arms changed to 3 from 4, planned number of patients changed from 60 to 132.
  • 16 Aug 2023 Status changed from not yet recruiting to recruiting.
  • 26 May 2023 According to a Shanghai Henlius Biotech media release, the investigational new drug application (IND) for a phase 2 clinical trial of serplulimab in combination with HLX26 for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA).

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