Analysis of Gut Microbiota in Patients With Brain Metasta... | NCT04333004

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Apr 1, 2020

First Submission Date that Met QC Criteria

Apr 1, 2020

First Posted Date

Apr 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaorong Dong, Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Xiaorong DongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pembrolizumab Combined With Chemotherapy	Experimental		Drug: Pembrolizumab Combined With Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab Combined With Chemotherapy	Drug	Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks	Pembrolizumab Combined With Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diversity of gut microbiota	Species and abundance of gut microbiota	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms