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

Hui Bu

Status and phase: Unknown; Phase 4

Conditions: Leptomeningeal Metastasis; Durvalumab

Treatments: Drug: Durvalumab; Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04356222

BH 004

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Leptomeningeal Metastasis

Experimental group

Description:

Durvalumab + Intrathecal chemotherapy

Treatment:

Drug: Durvalumab

Drug: methotrexate