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

Phase 1

• Conditions: Gut Microbiota; NSCLC; Pembrolizumab; Chemotherapy
• Interventions: Drug: Pembrolizumab Combined With Chemotherapy

• Registration Number: NCT04333004
• Lead Sponsor: Xiaorong Dong

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 available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03
• Primary Completion: 2021-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab Combined With Chemotherapy	Pembrolizumab Combined With Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
diversity of gut microbiota	1 year	Species and abundance of gut microbiota