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NCT06616532

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

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2028-12-25

Brief Summary

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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

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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.

Conditions

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SCLC

Keywords

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Second-line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PM8002+Paclitaxel

Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.

Group Type EXPERIMENTAL

PM8002

Intervention Type DRUG

Following a predefined dose and date.

Paclitaxel

Intervention Type DRUG

175mg/m2 via IV infusion on Day 1 Q3W

Chemotherapy

Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

175mg/m2 via IV infusion on Day 1 Q3W

Topotecan

Intervention Type DRUG

1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Interventions

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PM8002

Following a predefined dose and date.

Intervention Type DRUG

Paclitaxel

175mg/m2 via IV infusion on Day 1 Q3W

Intervention Type DRUG

Topotecan

1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Cheng

Role: PRINCIPAL_INVESTIGATOR

Jilin Provincial Tumor Hospital

Locations

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