NCT04333004

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2020

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 1, 2020

Last Update Submit

April 1, 2020

Conditions

Gut MicrobiotaNSCLCPembrolizumabChemotherapy

Outcome Measures

Primary Outcomes (1)

  • diversity of gut microbiota

    Species and abundance of gut microbiota

    1 year

Study Arms (1)

Pembrolizumab Combined With Chemotherapy

EXPERIMENTAL
Drug: Pembrolizumab Combined With Chemotherapy

Interventions

Pembrolizumab Combined With ChemotherapyDRUG

Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks

Pembrolizumab Combined With Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

April 3, 2020

Record last verified: 2020-04