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Active Not Recruiting NCT06616532

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

Conditions: SCLC

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 404
Sponsor: Biotheus Inc.

Location: Binzhou Medical University Hospital Binzhou

Summary

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

Eligibility Criteria

Inclusion Criteria: 1. 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; 2. Age ≥18 years but ≤75 years; 3. Histologically or cytologically confirmed SCLC; 4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors); 5. Having adequate organ functions; 6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; 7. Life expectancy of 12 weeks or more; 8. Having at least one measurable tumor lesion according to RECIST v1.1; Exclusion Criteria: 1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs; 3. Current presence of severe superior vena cava syndrome and spinal cord compression; 4. 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; 5. Evidence of significant clotting disorder or other significant bleeding risk; 6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months; 7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 10. History of alcohol abuse, psychotropic substance abuse or drug abuse; 11. Pregnant or lactating women; 12. Other conditions considered unsuitable for this study by the investigator.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06616532). StuddyBuddy aggregates publicly available trial information.