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

Sponsored by Biotheus Inc.

About this trial

Last updated a year ago

Study ID

PM8002-C014C-SCLC-R

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18 to 75 Years
All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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

What are the participation requirements?

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.