Clinical Trial

Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs

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Record status
This record was last updated January 9, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Research objective Main purpose Exploring the real-world effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis after EGFR-TKIs resistance. Outcome measure: Real world intracranial disease-free survival time (iPFS). Secondary purpose Federation patterns: describing different treatment modes in the real world; Outcome measures: Combination chemotherapy regimen and duration of chemotherapy. Efficacy: Further explore the effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis failed with EGFR-TKI treatment; Outcome measures: Objective response rate (LM-ORR), duration of intracranial response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, CSF response rate based on CSF cytology. Safety: Explore the safety of Ivonescimab combined with chemotherapy for NSCLC patients with leptomeningeal metastases who have failed EGFR-TKI treatment; Outcome measures: incidence of adverse events (TEAEs), laboratory test outliers, and serious adverse events (SAEs). Research endpoint Primary endpoint * iPFS (intracranial progression free survival). Secondary endpoint * Efficacy: leptomeningeal ORR (LM-ORR), intracranial duration of response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, and CSF response rate based on CSF cytology; * Safety: Determine the incidence and severity of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE5.0 standards; Changes in vital signs, laboratory abnormalities, and quality of life scores. Exploratory endpoint: efficacy related biomarkers
Trial Details
NCT Number NCT06766591
Lead Sponsor Jiangsu Province Nanjing Brain Hospital
Collaborators: Henan Cancer Hospital, Three Gorges Hospital of Chongqing University
Conditions NSCLC, Chemotherapy, Leptomeningeal Metastases, EGFR-TKI, AK112
Enrollment 36 participants
Start Date 2025-01-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-09