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A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

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Trial Profile

A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2026

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At a glance

  • Drugs HLX 43 (Primary) ; Docetaxel; Pimurutamab
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 04 May 2026 According to a Shanghai Henlius Biotech media release, company announced HLX43 has received implied approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its Phase II/III international multicenter clinical trial (HLX43-NSCLC302) in advanced squamous non-small cell lung cancer (sqNSCLC).
  • 27 Apr 2026 According to a Henlius Biopharmaceuticals media release, data from this trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 29th to June 2nd.
  • 13 Mar 2026 Status changed from not yet recruiting to recruiting.

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