Back to resultsAnalysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
Primary Purpose
Gut Microbiota, NSCLC, Pembrolizumab
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pembrolizumab Combined With Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gut Microbiota
Eligibility Criteria
Inclusion Criteria:
- non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before
Exclusion Criteria:
- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pembrolizumab Combined With Chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
diversity of gut microbiota
Species and abundance of gut microbiota
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04333004
Brief Title
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
Official Title
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaorong Dong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, NSCLC, Pembrolizumab, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab Combined With Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab Combined With Chemotherapy
Intervention Description
Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks
Primary Outcome Measure Information:
Title
diversity of gut microbiota
Description
Species and abundance of gut microbiota
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before
Exclusion Criteria:
- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis
12. IPD Sharing Statement
Learn more about this trial
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
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