PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.

Inclusion criteria

• Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
• Age ≥18 years but ≤75 years;
• Histologically or cytologically confirmed SCLC;
• Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
• Having adequate organ functions;
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• Life expectancy of 12 weeks or more;
• Having 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;
• Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
• Current presence of severe superior vena cava syndrome and spinal cord compression;
• Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
• Evidence of significant clotting disorder or other significant bleeding risk;
• History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
• Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol abuse, psychotropic substance abuse or drug abuse;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.