A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination with Pembrolizumab Versus Chemotherapy in Combination with Pembrolizumab As First-Line Treatment for PD-L1 Negative Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
• Histologically or cytologically confirmed non-squamous NSCLC, and unsuitable for radical surgery and/or radical concurrent/sequential radiochemotherapy, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC;
• EGFR-sensitive mutation negative \[no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)\] and ALK fusion gene negative, without known ROS1 gene fusion, NTRK gene fusion, BRAF V600E mutation, etc. that have been approved for targeted therapy driving gene alterations;
• No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC;
• Participants whose tumours are PD-L1 TPS ≥ 1%;
• At least one measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization;
• A life expectancy of at least 12 weeks;
• Adequate organ and bone marrow function;