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

Hui Bu30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leptomeningeal Metastasis Durvalumab

Interventions

DurvalumabDRUG

Intravenous infusion once every two weeks ,once 10mg/kg.

methotrexateDRUG

Intrathecal chemotherapy specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and Female age 18 or more 2. Pathologically proven non-small cell lung cancer 3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid 4. Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. KPS score \<60 2. History of autoimmune diseases 3. With severe hepatic and renal dysfunction 4. Has a history of (non-infectious) pneumonitis that required steroids

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 36 months

The incidence of adverse reactions

In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks

Time frame: 36 months

Secondary Outcomes

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

Time frame: 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)

Time frame: 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.

Time frame: 36 months

Central Contacts

Hui Bu

CONTACT

86-13831106903 buhuimy1@163.com

Data from ClinicalTrials.gov

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