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

May 22, 2020 updated by: Hui Bu

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Leptomeningeal Metastasis
Durvalumab + Intrathecal chemotherapy
Drug: Durvalumab
Intravenous infusion once every two weeks ,once 10mg/kg.
Drug: methotrexate
Intrathecal chemotherapy specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 36 months
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)
Time Frame: 36 months
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
Time Frame: 36 months
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
Neurological assessment
Time Frame: 36 months
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
Progression Free Survival(PFS)
Time Frame: 36 months
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)
Time Frame: 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Bu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (ACTUAL)

April 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH 004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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