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

Phase 4

• Conditions: Leptomeningeal Metastasis; Durvalumab
• Interventions: Drug: Durvalumab; Drug: methotrexate

• Registration Number: NCT04356222
• Lead Sponsor: Hui Bu

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27
• Study Start: 2020-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leptomeningeal Metastasis	methotrexate	Durvalumab + Intrathecal chemotherapy
Leptomeningeal Metastasis	Durvalumab	Durvalumab + Intrathecal chemotherapy

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	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)	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	36 months	In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	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)
Progression Free Survival(PFS)	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
Neurological assessment	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.