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

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: Leptomeningeal Metastasis; Durvalumab
• Intervention / Treatment: Drug: Durvalumab; Drug: methotrexate

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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
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
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

Collaborators and Investigators

• Sponsor: Hui Bu

Study record dates

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: Intrathecal chemotherapy; Durvalumab; Leptomeningeal Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Durvalumab; Methotrexate
• 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