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NCT04333004 Clinical Trial

Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

NSCLC Clinical Trial

Official title:
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04333004
Other study ID # 1
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2020
Est. completion date April 2022

Study information
Verified date April 2020
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date April 2022
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pembrolizumab Combined With Chemotherapy
Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xiaorong Dong

Outcome
Type Measure Description Time frame Safety issue
Primary diversity of gut microbiota Species and abundance of gut microbiota 1 year
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