Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Overview
- Phase
- Phase 4
- Intervention
- Durvalumab
- Conditions
- Leptomeningeal Metastasis
- Sponsor
- Hui Bu
- Enrollment
- 30
- Primary Endpoint
- overall survival (OS)
- Last Updated
- 5 years ago
Overview
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
Investigators
Hui Bu
Study Principal Investigator
Hebei Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •KPS score \<60
- •History of autoimmune diseases
- •With severe hepatic and renal dysfunction
- •Has a history of (non-infectious) pneumonitis that required steroids
Arms & Interventions
Leptomeningeal Metastasis
Durvalumab + Intrathecal chemotherapy
Intervention: Durvalumab
Leptomeningeal Metastasis
Durvalumab + Intrathecal chemotherapy
Intervention: methotrexate
Outcomes
Primary Outcomes
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
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
The incidence of adverse reactions
Time Frame: 36 months
In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks
Secondary Outcomes
- Objective response rate (ORR)(36 months)
- Progression Free Survival(PFS)(36 months)
- Neurological assessment(36 months)