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

NCT04833205 | Unknown Phase 2 DMC

• 1 other identifier: BH005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Leptomeningeal Metastasis; Lung Cancer

Keywords

Leptomeningeal Metastasis; ,Nimotuzumab; Lung Cancer; EGFR-TKI

Outcome Measures

Primary Outcomes (1)

• progression free survival

  From the diagnosis of the LM to the time of disease worsen

  2 years

Secondary Outcomes (2)

• Overall Survival

  2 years

• Incidence of Treatment-Emergent Adverse Events

  8Weeks

Study Arms (1)

Leptomeningeal metastases received EGFR-TKI and Nimotuzumab

EXPERIMENTAL

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

Interventions

Nimotuzumab DRUG

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

Also known as: EGFR-TKI

Leptomeningeal metastases received EGFR-TKI and Nimotuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hui Bu: lead

Study Sites (2)

The Second Hospital of Hebei Medical University

Hebei, Shijiazhuang/hebei, 050000, China

RECRUITING

The Second Hospital of Hebei Medical University

Hebei, China

RECRUITING

MeSH Terms

Conditions

Meningeal Carcinomatosis; Lung Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• jiao xue qi, master

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hui bu, PhD

CONTACT

0311-66003711-211; buhuimy1@163.com

jiao xue qi, master

CONTACT

1074234012@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The department of neurology,clincial professor,director

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 6, 2021
• Study Start: April 19, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2023
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)