Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases (OMESIA)

April 7, 2023 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases：A Retrospective Study

Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with brain metastasis received immunotherapy

Description

Inclusion Criteria:

  • 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs

Exclusion Criteria:

  • 1.Patients with a clear driver mutation that can be targeted for first-line treatment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chemotherapy alone or chemotherapy combined with anti-angiogenesis
patients with Chemotherapy
immuntherapy
patients treated with immune checkpoint inhibitor monotherapy or combination therapy.
Drug: immune therapy
The patient receives immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: November 2017- October 2021
disease remission rate
November 2017- October 2021
PFS
Time Frame: November 2017- October 2021
progression free survival
November 2017- October 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: November 2017- October 2021
Overall survival
November 2017- October 2021

Collaborators and Investigators

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

Sponsor

Hunan Province Tumor Hospital

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 (Actual)

November 3, 2017

Primary Completion (Actual)

September 5, 2021

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMESIA

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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