This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.
This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Drug: ivonescimab 20mg/kg, IV, D1, Q3W Other Names: AK112 Drug: irinotecan liposome(II) 70mg/m\^2, IV, D1, Q3W
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Time frame: Up to approximately 2 years
Objective response rate(ORR)
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame: Up to 30 days after last treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.