A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
NCT06954246 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2025-06-18
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).
Conditions
- Small Cell Lung Cancer Extensive Stage
Interventions
- 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
-
65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
- DRUG
-
135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-04
- Primary Completion
- 2027-05-31
- Completion
- 2028-04-30
Countries
- China
Study Locations
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