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

Biotheus

Status and phase: Enrolling; Phase 3

Conditions: SCLC

Treatments: Drug: PM8002; Drug: Paclitaxel; Drug: Topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616532

PM8002-C014C-SCLC-R

Details and patient eligibility

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

Full 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.

Enrollment: 404 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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404 participants in 2 patient groups

PM8002+Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel

Drug: PM8002

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Topotecan

Drug: Paclitaxel