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

Launched by BIOTHEUS INC. · Sep 25, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment for small cell lung cancer (SCLC), specifically looking at the combination of a drug called PM8002 with Paclitaxel. PM8002 is a special type of medication designed to target specific proteins that can help cancer grow. This trial is aimed at patients who have already received chemotherapy and whose cancer has either progressed or come back. It’s a Phase 3 trial, which means researchers are testing how well this new treatment works compared to standard chemotherapy in patients whose cancer has not improved with earlier treatments.

To be eligible for this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of advanced SCLC. They should have experienced cancer progression after their first treatment and have a good performance status, meaning they are generally able to carry out daily activities without much difficulty. Participants can expect to undergo various tests to monitor their health and the effectiveness of the treatment throughout the study. It’s important to note that certain medical conditions and previous treatments may exclude potential participants from joining the trial. If you or someone you know is interested in this study, it's a good idea to talk to a healthcare provider for more information.

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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.