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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Leptomeningeal Metastasis
• Intervention / Treatment: Drug: Nimotuzumab

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei, China
    • Recruiting
    • The Second Hospital of Hebei Medical University
  • Shijiazhuang/hebei
    • Hebei, Shijiazhuang/hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	From the diagnosis of the LM to the time of disease worsen	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	From the diagnosis of theLM to the time of death	2 years
Incidence of Treatment-Emergent Adverse Events	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"	8Weeks

Collaborators and Investigators

• Sponsor: Hui Bu
• Investigators: Principal Investigator: jiao xue qi, master, The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 19, 2021
• Primary Completion (Anticipated): April 19, 2022
• Study Completion (Anticipated): April 19, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Lung Cancer; EGFR-TKI; Leptomeningeal Metastasis; ,Nimotuzumab
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: BH005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No