Non Small Cell Lung CancerOMESIANCT05129202
Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases
An observational study of Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- immune therapy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2017to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain metastasis received immunotherapy
Who may be able to join
- 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs
Who cannot join
- 1.Patients with a clear driver mutation that can be targeted for first-line treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- immune therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immune therapyDrug
The patient receives immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy alone or chemotherapy combined with anti-angiogenesis | patients with Chemotherapy | |
| immuntherapy | patients treated with immune checkpoint inhibitor monotherapy or combination therapy. Receives: Drug: immune therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
disease remission rate
Measured: November 2017- October 2021
PFS
progression free survival
Measured: November 2017- October 2021
Secondary outcomes (1)
OS
Overall survival
Measured: November 2017- October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start3 Nov 2017
- Primary completion5 Sep 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang C Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129202
- Sponsor's protocol ID
- OMESIA
- Acronym
- OMESIA
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37195128
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases：A Retrospective Study
- ClinicalTrials.gov ID
- NCT05129202
- Acronym / sponsor ID
- OMESIA / OMESIA
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy alone or chemotherapy combined with anti-angiogenesis | – | –patients with Chemotherapy |
| immuntherapy | – | Drug: immune therapypatients treated with immune checkpoint inhibitor monotherapy or combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain metastasis received immunotherapy
Key inclusion criteria (1 listed)
- 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs
Key exclusion criteria (1 listed)
- 1.Patients with a clear driver mutation that can be targeted for first-line treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immune therapyThe patient receives immunotherapy | Drug | immuntherapy |
Primary outcome
ORR
Time frame: November 2017- October 2021
disease remission rate
PFS
Time frame: November 2017- October 2021
progression free survival
1 secondary outcome
OS
Time frame: November 2017- October 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 37195128Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongchang C Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: November 2017- October 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.