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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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
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