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NCT05129202 Clinical Trial

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

Non Small Cell Lung Cancer Clinical Trial

— OMESIA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05129202
Other study ID # OMESIA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 3, 2017
Est. completion date October 1, 2022

Study information
Verified date April 2023
Source Hunan Province Tumor Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 1, 2022
Est. primary completion date September 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• immune therapy
The patient receives immunotherapy

Locations
Country Name City State
China Hunan Cancer Hospital Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ORR disease remission rate November 2017- October 2021
Primary PFS progression free survival November 2017- October 2021
Secondary OS Overall survival November 2017- October 2021
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