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
Age range: 18-75y
EGFR mutation NSCLC
LM was diagnosed through head enhanced MRI or (and) CSF cytology
EGFR activation mutations were positive
Patients with squamous cell carcinoma, large cell carcinoma, mixed cell lung cancer
The patient has other driver genes that can be treated with targeted drugs
Subjects who have previously received immunotherapy with a discontinuation time of less than 3 months
Received EGFR-TKI treatment within one week prior to the first administration
Single group
Ivonescimab combined with chemotherapy
DrugIvonescimab combined with chemotherapy. The specific chemotherapy regimen is based on the real world.
intracranial progression free survival(iPFS)
Treatment initiation to intracranial progression/death/deadline for last follow-up
PFS
Treatment start to PD/death/deadline for last follow-up
OS
The time from randomization to death (for any reason)
iDoR
The time from the first assessment of intracranial lesions as CR or PR to the first assessment as PD or death from any cause
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Jiangsu Province Nanjing Brain Hospital
Lead sponsor
Henan Cancer Hospital
Collaborator
Three Gorges Hospital of Chongqing University
Collaborator
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