A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer

Inclusion Criteria

• •1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• •2. Aged ≥18 and ≤75 years, male or female.
• •3. ECOG PS 0 or 1.
• •4. Life expectancy ≥ 3 months.
• •9. Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
• •10. Has an uncontrolled concurrent disease.
• •11. Presence of severe uncontrolled cardiovascular disorder.
• •12. History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/pneumonitis
• •13. Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
• •14. Chronic autoimmune or inflammatory diseases requiring or receiving systemic therapy within 2 years prior to the first dose.
• •15. Serious infections within 4 weeks prior to the first dose.
• •16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• •17. Unresolved toxicities from previous antitumor therapy.
• •18. Known hypersensitivity to any component of any study drug; history of severe allergy or known history of serious hypersensitivity to other monoclonal antibodies or recombinant protein products, or history of severe infusion reactions.
• •19. Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.
• •20. Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.