NCT06954246

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

A Phase 3, Multicenter, Randomized, Open-label Study of MHB088C for Injection Versus Treatment of Physician's Choice (TPC) in Comparing the Efficacy and Safety in Subjects With Relapsed Small Cell Lung Cancer (SCLC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).

Detailed description

The primary objective of this study is to assess whether treatment with MHB088C for Injection improves prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of MHB088C for Injection, immunogenicity of MHB088C, and characterize the pharmacokinetics of MHB088C.

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	MHB088C for Injection	2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
DRUG	Topotecan	1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
DRUG	Irinotecan	65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
DRUG	Paclitaxel	135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-05-01
• Completion: 2028-04-01
• First posted: 2025-05-01
• Last updated: 2025-06-18

Locations

1 site across 1 country: China