Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06766591

Not yet recruiting

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

Interventional

Phase not listed

Sponsor: Jiangsu Province Nanjing Brain Hospital

Last Updated: January 9, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Treatment Category

Chemotherapy, Monoclonal Antibodies

Required Mutations

None

Trial Started

January 1, 2025

Last Updated by Sponsor

January 9, 2025

Estimated Completion

October 31, 2025

Contact Study

Name:Cun shen Fang, Dr

Email:fang1984@aliyun.com

Phone:13404163638

Eligibility

Inclusion Criteria

* Age range: 18-75y

* EGFR mutation NSCLC

* LM was diagnosed through head enhanced MRI or (and) CSF cytology

* EGFR activation mutations were positive

* Patients who have failed to first or second-generation EGFR-TKI treatment，without T790M mutation; or failed to third-generation EGFR-TKI treatment

* Hematological, coagulation, renal and liver function is sufficient

* Women of childbearing age must undergo a pregnancy test and the result must be negative

Exclusion Criteria

* 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

* Received non-specific immunomodulatory therapy

* Clinical manifestations of neurological failure

* Non malignant neurological disorders

* Radiotherapy for the chest and whole brain should be completed within 4 weeks before enrollment

* Tumor surrounded important blood vessels or had obvious necrosis or cavities

* Tumor has invaded important surrounding organs and blood vessels

* History of severe bleeding tendency or coagulation dysfunction

* The risk of developing esophagotracheal fistula or esophageal pleural fistula

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll36

Arms & Interventions

Arms

Interventions

Type: Experimental

Description:

Interventions:

Ivonescimab combined with chemotherapy

Outcome Measures

Primary Outcome Measures

intracranial progression free survival(iPFS)From enrollment to the end of treatment at 12 months

Treatment initiation to intracranial progression/death/deadline for last follow-up

Secondary Outcome Measures

PFSFrom enrollment to the end of treatment at 12 months

Treatment start to PD/death/deadline for last follow-up

OSFrom enrollment to the end of treatment at 18 months

The time from randomization to death (for any reason)

iDoRFrom 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