A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06478043
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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 extensive stage small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.

Key Dates

Start date
Sep 1, 2024
Status verified
Jul 2024
Primary completion
Sep 1, 2025
Completion
Sep 1, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ivonescimab and irinotecan liposome
    Subjects receive ivonescimab plus irinotecan liposome until progression.

Primary Outcome Measure

Objective response rate（ORR） [ Time Frame: Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years ]

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