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

Sponsor

Hui Bu (Other)

Overall Status

Recruiting

CT.gov ID

NCT04833205

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Leptomeningeal Metastasis Lung Cancer	Drug: Nimotuzumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 19, 2021

Anticipated Primary Completion Date :

Apr 19, 2022

Anticipated Study Completion Date :

Apr 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Leptomeningeal metastases received EGFR-TKI and Nimotuzumab 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	Drug: Nimotuzumab Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks Other Names: EGFR-TKI

Arm

Intervention/Treatment

Experimental: Leptomeningeal metastases received EGFR-TKI and Nimotuzumab

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

Drug: Nimotuzumab

Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks

Other Names:

EGFR-TKI

Outcome Measures

Primary Outcome Measures

progression free survival [2 years]
From the diagnosis of the LM to the time of disease worsen

Secondary Outcome Measures

Overall Survival [2 years]
From the diagnosis of theLM to the time of death
Incidence of Treatment-Emergent Adverse Events [8Weeks]
When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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