This is a multicenter, open-label, single-arm phase 2 study evaluating the efficacy and safety of ivonescimab combined with paclitaxel polymeric micelles in adults with recurrent or refractory small cell lung cancer after failure of platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
This multicenter, open-label, single-arm phase II investigator-initiated study evaluates the efficacy and safety of ivonescimab combined with paclitaxel polymeric micelles in adults with recurrent or refractory small cell lung cancer after failure of platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Participants will receive ivonescimab 20 mg/kg intravenously on Day 1 every 3 weeks, followed at least 30 minutes later by paclitaxel polymeric micelles 230 mg/m² intravenously over at least 3 hours on Day 1 every 3 weeks. Paclitaxel polymeric micelles will be administered for up to 4 cycles. Ivonescimab may continue for up to 2 years or until disease progression, initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation. Tumor response will be assessed by investigators using RECIST v1.1 every 6 weeks during the first 12 months and every 9 weeks thereafter. The primary endpoint is objective response rate. Secondary endpoints include disease control rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and safety assessed using NCI CTCAE version 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Paclitaxel polymeric micelles 230 mg/m² are administered intravenously over at least 3 hours on Day 1 of each 3-week cycle, at least 30 minutes after ivonescimab infusion. Treatment is given for a maximum of 4 cycles or until initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation.
Ivonescimab 20 mg/kg is administered intravenously on Day 1 of each 3-week cycle. It is administered before paclitaxel polymeric micelles. Treatment continues for up to 2 years or until disease progression, initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Outcome Objective Response Rate (ORR) assessed by RECIST v1.1
The percentage of participants with a confirmed complete response or partial response, assessed by investigators according to RECIST version 1.1.
Time frame: Up to 36 months
Disease Control Rate (DCR)
The percentage of participants with complete response, partial response, or stable disease, assessed by investigators according to RECIST version 1.1.
Time frame: Up to 36 months
Clinical Benefit Rate (CBR)
The percentage of participants with an objective response or stable disease lasting at least 4 months, assessed by investigators according to RECIST version 1.1.
Time frame: Up to 36 months
Duration of Response (DOR)
The time from the first documented complete or partial response to the first documented disease progression, recurrence, or death from any cause.
Time frame: Up to 36 months
Progression-Free Survival (PFS)
The time from first study treatment to documented disease progression or death from any cause, whichever occurs first.
Time frame: Up to 36 months
Overall Survival (OS)
The time from first study treatment to death from any cause; participants alive at analysis are censored at the last known alive date or clinical cutoff date.
Time frame: Up to 36 months
Number of participants with Adverse Events
Incidence and severity of adverse events, serious adverse events, laboratory abnormalities, vital-sign abnormalities, physical examination findings, and electrocardiogram abnormalities; severity is assessed using NCI CTCAE version 5.0.
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Time frame: From first dose through 30 days after the last study treatment, up to approximately 25 months