An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

• Histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC not suitable for radical treatment (complete surgical resection, concurrent/sequential radio-chemotherapy) according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition), and should meet the following criteria:

  1. Subjects without actionable genomic alterations (AGAs):

     • Subjects with non-squamous NSCLC must have documented negative test results for EGFR and ALK alterations. If no prior test results for EGFR and ALK are available, subjects must undergo EGFR and ALK testing at the study site. For subjects with squamous NSCLC, EGFR and/or ALK testing is not required prior to enrollment if their status is unknown;
     • No other known actionable genomic alterations, such as ROS1, NTRK, BRAF, MET exon 14 skipping, and RET;
     • Prior standard treatment failure of ≥ 1 line, including at least anti-PD-(L)1 antibody and platinum-based chemotherapy;

  2. Subjects with AGAs:

     • Previous test results confirming the presence of one or more actionable genomic alterations;
     • Prior standard treatment failure of ≥ 1 line, including at least targeted therapy for driver gene alterations (patients with EGFR mutations must be previously treated with EGFR inhibitors) and platinum-based chemotherapy;
• At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization;
• ECOG PS score of 0-1
• No small cell, neuroendocrine, or sarcomatoid
• No second malignancy within 2 years except early-stage that have received curative treatment
• No prior treatment with any topo-I targeting agent
• No severe lung disase
• No severe cardiac disease
• No steroids within 2 weeks
• No autoimmune disease except treated hypothyroidism or DM Type 1
• No active HIV, HBV, HCV

• Primary
  • ORR
• Secondary
  • ORR by investigator
  • PFS
  • OS
  • Safety