A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Inclusion criteria

• Signed informed consent form before any trial-related processes;
• Age ≥18 years;
• Histologically or cytologically confirmed SCLC;
• Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
• 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

• History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
• Evidence and history of severe bleeding tendency;
• History of severe cardiovascular diseases within 6 months;
• Current presence of severe superior vena cava syndrome and spinal cord compression;
• 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.