A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC
- Sponsor
- Zhejiang Cancer Hospital
- Study ID
- NCT06478043
- Phase
- PHASE2
- Status
- Completed
Conditions
- Extensive-stage Small-cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- ivonescimab — DRUG20mg/kg, IV, D1, Q3W
- irinotecan liposome — DRUG56.5mg/m\^2, IV, D1, Q2W
Study Details
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.
Key Dates
- First listed
- Jun 27, 2024
- Start date
- Oct 16, 2024
- Status verified
- Feb 2026
- Primary completion
- Oct 22, 2024
- Completion
- Aug 27, 2025
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ivonescimab and irinotecan liposomeSubjects receive ivonescimab plus irinotecan liposome until progression.
Primary Outcome Measure
6-month PFS (progression free survival) rate [ Time Frame: From the day treatment started to 6 months ]
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