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NCT06820762PHASE2NOT_YET_RECRUITING

Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study

Sponsor: The Second Affiliated Hospital of Dalian Medical University + Shengjing Hospital

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
SCLC
Interventions
irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity
Enrollment
40 participants
Primary completion
Dec 2026
Study completion
Dec 2027
First posted
Feb 2025
Last updated
Feb 2025

Primary Endpoints (CT.gov)

Progression free survival (PFS)

Time frame: Up to approximately 2 years

Secondary Endpoints

Objective response rate(ORR)

Disease control rate (DCR)

Overall survival (OS)

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years; 2. Histologically or cytologically confirmed SCLC; 3. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors; 4. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; 5. Life expectancy of ≥3 months; 6. At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1(Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions) 7. No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment 8. Have adequate organ function; 9. All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug. 10. Able and willing to provide a written informed consent; Exclusion

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov