RecruitingPhase 3NCT06616532
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
Sponsor
Biotheus Inc.
Enrollment
404 participants
Start Date
Nov 13, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria12
- 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.
Interventions
DRUGPM8002
Following a predefined dose and date.
DRUGPaclitaxel
175mg/m2 via IV infusion on Day 1 Q3W
DRUGTopotecan
1.25mg/m2/day via IV infusion on Days 1-5 Q3W
Locations(45)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06616532
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