A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.

Inclusion criteria

Key Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy.
• No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
• 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.

Exclusion criteria

Key Exclusion Criteria:

• Active second malignancy.
• Uncontrolled or clinical significant cardiovascular disease.
• History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
• Active infection requiring systemic therapy within 2 weeks of randomization.
• Active hepatitis B or hepatitis C virus infection.
• Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known allergy to SKB264 or pembrolizumab or any of its components.
• Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):

• Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4 antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy;
• Therapy targeting TROP2.
• Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
• Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
• Pregnant or lactating women.