Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2020
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 27, 2020
May 1, 2020
3 years
April 18, 2020
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Progression Free Survival(PFS)
36 months
Objective response rate (ORR)
36 months
Neurological assessment
36 months
Study Arms (1)
Leptomeningeal Metastasis
EXPERIMENTALDurvalumab + Intrathecal chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- KPS score \<60
- History of autoimmune diseases
- With severe hepatic and renal dysfunction
- Has a history of (non-infectious) pneumonitis that required steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hui Bulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Bu
The Second Hospital of Hebei Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
April 18, 2020
First Posted
April 22, 2020
Study Start
June 1, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
May 27, 2020
Record last verified: 2020-05