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

Phase 2

• Conditions: Leptomeningeal Metastasis; Lung Cancer
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT04833205
• Lead Sponsor: Hui Bu

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-03
• Study First Posted: 2021-04-06
• Last Update Submitted: 2021-04-18
• Study Start: 2021-04-19
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-04-19
• Study Completion: 2023-04-19

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leptomeningeal metastases received EGFR-TKI and Nimotuzumab	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

Primary Outcome Measures

Name	Time	Method
progression free survival	2 years	From the diagnosis of the LM to the time of disease worsen

Secondary Outcome Measures

Name	Time	Method
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"

Trial Locations

Locations (1)

The Second Hospital of Hebei Medical University; 🇨🇳 Hebei, China