Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases
OMESIA
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedApril 10, 2023
April 1, 2023
3.8 years
November 10, 2021
April 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
ORR
disease remission rate
November 2017- October 2021
PFS
progression free survival
November 2017- October 2021
Secondary Outcomes (1)
OS
November 2017- October 2021
Study Arms (2)
Chemotherapy alone or chemotherapy combined with anti-angiogenesis
patients with Chemotherapy
immuntherapy
patients treated with immune checkpoint inhibitor monotherapy or combination therapy.
Interventions
Eligibility Criteria
Patients with brain metastasis received immunotherapy
You may qualify if:
- Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs
You may not qualify if:
- Patients with a clear driver mutation that can be targeted for first-line treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Related Publications (1)
Huang Z, Wu F, Xu Q, Song L, Zhang X, Wang Z, Deng L, Zhang Y, Zeng L, Yang N. Intracranial activity of first-line immune checkpoint inhibitors combined with chemotherapy in advanced non-small cell lung cancer. Chin Med J (Engl). 2023 Jun 20;136(12):1422-1429. doi: 10.1097/CM9.0000000000002720. Epub 2023 May 17.
PMID: 37195128DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongchang C Zhang, MD
Hunan Cancer Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
November 3, 2017
Primary Completion
September 5, 2021
Study Completion
October 1, 2022
Last Updated
April 10, 2023
Record last verified: 2023-04