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

April 1, 2020 updated by: Xiaorong Dong
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab Combined With Chemotherapy
Drug: Pembrolizumab Combined With Chemotherapy
Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaorong Dong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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