A 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
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. 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; 3. No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC; 4. Participants whose tumours are PD-L1 TPS \< 1%; 5. At least one measurable lesion per RECIST v1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization; 7. A life expectancy of at least 12 weeks; 8. Adequate organ and bone marrow function; Exclusion Criteria: 1. Histologically or cytologically confirmed t