NCT06616532

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SCLC

Interventions

Type	Name	Description
DRUG	PM8002	Following a predefined dose and date.
DRUG	Paclitaxel	175mg/m2 via IV infusion on Day 1 Q3W
DRUG	Topotecan	1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Timeline

• Start date: 2024-11-13
• Primary completion: 2027-01-25
• Completion: 2028-12-25
• First posted: 2024-09-27
• Last updated: 2024-12-19

Locations

45 sites across 1 country: China