A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

The study is divided into two parts.

The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.

The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.

Inclusion criteria

• Signed informed consent form before any trial-related processes;
• Age ≥18 years;
• Histologically or cytologically confirmed ES-SCLC;
• No prior systemic therapy for ES-SCLC;
• Have adequate organ function;
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• Life expectancy of ≥12 weeks;
• Had at least one measurable tumor lesion according to RECIST v1.1.

Exclusion criteria

• Histologically or cytologically confirmed mixed SCLC;
• History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
• The toxicity of previous anti-tumor therapy has not been alleviated；
• Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
• Evidence and history of severe bleeding tendency;
• History of severe cardiovascular diseases within 6 months;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol abuse, psychotropic substance abuse or drug abuse;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.