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Trial Title:
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
NCT ID:
NCT06616532
Condition:
SCLC
Conditions: Official terms:
Small Cell Lung Carcinoma
Paclitaxel
Topotecan
Conditions: Keywords:
Second-line
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
Following a predefined dose and date.
Arm group label:
PM8002+Paclitaxel
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
175mg/m2 via IV infusion on Day 1 Q3W
Arm group label:
Chemotherapy
Arm group label:
PM8002+Paclitaxel
Intervention type:
Drug
Intervention name:
Topotecan
Description:
1.25mg/m2/day via IV infusion on Days 1-5 Q3W
Arm group label:
Chemotherapy
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
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Provincial Tumor Hospital
Address:
City:
Changchun
Country:
China
Contact:
Last name:
Ying Cheng
Start date:
October 25, 2024
Completion date:
December 25, 2028
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06616532
