Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Study Overview
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Brief Summary
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The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis

Official Title
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Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Conditions
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Leptomeningeal Metastasis, Durvalumab

Intervention / Treatment
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* Drug: Durvalumab
* Drug: methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female age 18 or more Pathologically proven non-small cell lung cancer MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: KPS score <60 History of autoimmune diseases With severe hepatic and renal dysfunction Has a history of (non-infectious) pneumonitis that required steroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leptomeningeal Metastasis<br>Durvalumab + Intrathecal chemotherapy | Drug: Durvalumab<br>* Intravenous infusion once every two weeks ,once 10mg/kg.<br>Drug: methotrexate<br>* Intrathecal chemotherapy specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive | 36 months | 
| Neurological Progression Free Survival(NPFS) | NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause | 36 months | 
| The incidence of adverse reactions | In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival(PFS) | NPFS was defined as the time between the start of treatment to the date of the first documented tumor progression as determined by investigators per RECIST 1.1,or death due to any cause | 36 months | 
| Objective response rate (ORR) | Investigator assessed ORR was defined as the number of subjects whose best objective response (OOR) was a confirmed complete response (CR) or confirmed partial response (PR) | 36 months | 
| Neurological assessment | In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy