RecruitingPhase 3NCT06954246

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)


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

450 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called MHB088C in people with small cell lung cancer (SCLC) that has spread throughout the body and stopped responding to standard treatments. Small cell lung cancer grows quickly and has limited treatment options once it progresses, so researchers are looking for new approaches. **You may be eligible if...** - You are 18 or older with confirmed extensive-stage small cell lung cancer (cancer that has spread widely) - Your cancer progressed after at least two rounds of treatment including platinum-based chemotherapy and an immunotherapy drug (PD-1/L1 inhibitor) - You have not received more than two prior treatment regimens - You have at least one measurable tumor and good organ function **You may NOT be eligible if...** - You have another active cancer diagnosed in the last 5 years - You have a mixed or transformed type of lung cancer (not pure SCLC) - You received chemotherapy within the past 4 weeks - Your overall health is not strong enough to tolerate cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMHB088C for Injection

2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle

DRUGTopotecan

1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle

DRUGIrinotecan

65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle

DRUGPaclitaxel

135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle


Locations(1)

Shanghai East Hospital

Shanghai, China

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NCT06954246


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