Ivonescimab Combined With Chemotherapy
DrugIvonescimab combined with chemotherapy. The specific chemotherapy regimen is based on the real world.
NCT Number: NCT06766591
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 opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ivonescimab combined with chemotherapy. The specific chemotherapy regimen is based on the real world.
Time frame: From enrollment to the end of treatment at 12 months
Treatment initiation to intracranial progression/death/deadline for last follow-up
Time frame: From enrollment to the end of treatment at 12 months
Treatment start to PD/death/deadline for last follow-up
Time frame: From enrollment to the end of treatment at 18 months
The time from randomization to death (for any reason)
Time frame: From enrollment to the end of treatment at 12 months
The time from the first assessment of intracranial lesions as CR or PR to the first assessment as PD or death from any cause
Contact information is provided by the study sponsor or research team.
Jiangsu Province Nanjing Brain Hospital
Other
Ivonescimab Combined With Chemotherapy for EGFR Mutant NSCLC With Leptomeningeal Metastasis After EGFR TKIs Resistance: A Multicenter Observational Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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