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

Exclusion Criteria

• •1. Active second malignancy.
• •2. Uncontrolled or clinical significant cardiovascular disease.
• •3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
• •4. Active infection requiring systemic therapy within 2 weeks of randomization.
• •5. Active hepatitis B or hepatitis C virus infection.
• •6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• •7. Known allergy to SKB264 or pembrolizumab or any of its components.
• •8. Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):
• •1. 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;
• •2. Therapy targeting TROP2.
• •3. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
• •9. Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
• •10. Pregnant or lactating women.