A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC

Prior treatment

• Undergone anti-angiogenic therapy prior to the first dose of study treatment.
• History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.

Other illness

• Patients with other cancer in 5 years.
• Evidence and history of severe bleeding tendency.
• History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs.
• Active infection requiring systemic therapy.
• Active hepatitis B/C, or HIV infection.
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
• History of alcohol abuse, psychotropic substance abuse or drug abuse.
• Other conditions considered unsuitable for this study by the investigator.

Other

• Active central nervous system (CNS) metastases.
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions.
• Pregnant or lactating women.

• 18 to 75 years old (at the time of inform consent obtained).
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• Histologically confirmed SCLC.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors.
• At least one measurable tumor lesion according to RECIST v1.1.
• Adequate organ function.
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.