Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer

Hui Bu

Status and phase: Unknown; Phase 2

Conditions: Leptomeningeal Metastasis; Lung Cancer

Treatments: Drug: Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04833205

BH005

Details and patient eligibility

About

Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 years or older, gender not limited;
• A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
• Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
• Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
• Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
• Bone marrow, liver, kidneys and blood clotting function are relatively stable

Exclusion criteria

• Eastern Cooperative Oncology Group scored > 2 points
• Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study

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 metastases received EGFR-TKI and Nimotuzumab

Experimental group

Description:

The patients received Nimotuzumab 200 mg,which was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping.And the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks.One the other hand,the patient received the third generation of EGFR-TKI

Treatment:

Drug: Nimotuzumab