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MHB088C vs TPC in Relapsed SCLC
NCT06954246Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- Qilu Pharmaceutical
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- MHB088C
- Conditions
- small cell lung cancer (SCLC)
01
Overview
Phase 3, randomised, open-label trial of MHB088C in small cell lung cancer (SCLC) (2 arms), sponsored by Qilu Pharmaceutical. Primary endpoint: Overall Survival at 5 years. Started Jun 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
MHB088C
MHB088C 2 mg/kg IV on D1, D15 q4w
TPC
Physician's Choice of Topotecan, Irinotecan, or Paclitaxel
03
Who it enrols
Adults with relapsed extensive-stage SCLC who have progressed after platinum-based and PD-1/L1 therapy (max 2 prior lines). Excludes patients with prior topo I inhibitor treatment, symptomatic brain metastases, or severe pulmonary disease.
04
Endpoints
Primary
Overall Survival
Secondary
Objective Response Rate
Progression-Free Survival
Duration of Response
Disease Control Rate
Incidence and Severity of Adverse Events
Maximum Concentration
Time to Maximum Concentration
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