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

NCT ID: NCT04356222

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2023-06-30

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

Detailed Description

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Conditions

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Leptomeningeal Metastasis Durvalumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Leptomeningeal Metastasis

Durvalumab + Intrathecal chemotherapy

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

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

methotrexate

Intervention Type DRUG

Intrathecal chemotherapy specified dose on specified days

Interventions

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Durvalumab

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

Intervention Type DRUG

methotrexate

Intrathecal chemotherapy specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui Bu

OTHER

Sponsor Role lead

Responsible Party

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Hui Bu

Study Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui Bu

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Central Contacts

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Hui Bu

Role: CONTACT

86-13831106903

Other Identifiers

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BH 004

Identifier Type: -

Identifier Source: org_study_id

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