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

Leptomeningeal Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04356222
• Other study ID #: BH 004
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2020
• Est. completion date: June 2023

Study information

• Verified date: May 2020
• Source: Hebei Medical University
• Contact: Hui Bu
• Phone: 86-13831106903
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Durvalumab
• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• Durvalumab
Intravenous infusion once every two weeks ,once 10mg/kg.
• methotrexate
Intrathecal chemotherapy specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Bu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The incidence of adverse reactions	In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks	36 months
Secondary	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
Secondary	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
Secondary	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