Back to resultsClinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
Primary Purpose
Leptomeningeal Metastasis, Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Leptomeningeal Metastasis focused on measuring Leptomeningeal Metastasis, ,Nimotuzumab, Lung Cancer, EGFR-TKI
Eligibility Criteria
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
Sites / Locations
- The Second Hospital of Hebei Medical UniversityRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Leptomeningeal metastases received EGFR-TKI and Nimotuzumab
Arm 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
Outcomes
Primary Outcome Measures
progression free survival
From the diagnosis of the LM to the time of disease worsen
Secondary Outcome Measures
Overall Survival
From the diagnosis of theLM to the time of death
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"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833205
Brief Title
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
Official Title
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2021 (Anticipated)
Primary Completion Date
April 19, 2022 (Anticipated)
Study Completion Date
April 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui Bu
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastasis, Lung Cancer
Keywords
Leptomeningeal Metastasis, ,Nimotuzumab, Lung Cancer, EGFR-TKI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Leptomeningeal metastases received EGFR-TKI and Nimotuzumab
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
EGFR-TKI
Intervention Description
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
Primary Outcome Measure Information:
Title
progression free survival
Description
From the diagnosis of the LM to the time of disease worsen
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
From the diagnosis of theLM to the time of death
Time Frame
2 years
Title
Incidence of Treatment-Emergent Adverse Events
Description
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"
Time Frame
8Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hui bu, PhD
Phone
0311-66003711-211
Email
buhuimy1@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
jiao xue qi, master
Email
1074234012@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jiao xue qi, master
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Hebei
State/Province
Shijiazhuang/hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui bu, phd
Phone
13831106903
Email
buhuimy1@163.com
Facility Name
The Second Hospital of Hebei Medical University
City
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui bu, phD
Phone
13831106903
Email
buhuimy1@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
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