Non-small Cell Lung CancerNCT06557967
Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment
An observational study of Non-small Cell Lung Cancer and Lung Cancer, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Lung Cancer, Metastatic Cancer
- What is being tested?
- No drug
- How many people
- 22,517 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 30 Sep 2024
- 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: Participants diagnosed with metastatic NSCLC between 2015-2023 treated with systemic therapy.
Who may be able to join
- Diagnosis of mNSCLC in study period (01/01/2015-06/30/2023) including newly diagnosed at metastatic stage or progression from advanced stage NSCLC
- Age 18+ years at the time of diagnosis of mNSCLC
- Additional inclusion criteria for 1st Line of Therapy cohort:
- Treated with systemic anti-cancer therapy in 1L setting
- Additional inclusion criteria for 2nd Line of Therapy and 3rd Line of Therapy cohorts:
- Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting
Who cannot join
- Evidence of other primary malignancy in the 365-day baseline period immediately prior to the first mNSCLC diagnosis in the study period
- Evidence of stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), or whole brain radiotherapy (WBRT) in the baseline period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Brain Metastases and Impact on Survival in Metastatic Non-small Cell Lung Cancer by Line of Treatment
This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes.
Read the detailed description
This retrospective cohort database study will generate real-world evidence describing prevalence of brain metastases at metastatic diagnosis and by line of therapy, patient characteristics, treatment patterns, and clinical outcomes in metastatic non-small cell lung cancer (mNSCLC) patients
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Metastatic Cancer, Brain and Central Nervous System Cancer
- Being tested
- No drug
- Keywords
- Real World Evidence, NSCLC, Brain metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis, Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is a non-interventional study and no study drug will be provided.
| Study group | Role | What they receive |
|---|---|---|
| mNSCLC - Overall | Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) Receives: Other: No drug | |
| mNSCLC - 1st Line of Therapy | Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in first line setting. Receives: Other: No drug | |
| mNSCLC - 2nd Line of Therapy | Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in second line setting. Receives: Other: No drug | |
| mNSCLC - 3rd Line of Therapy | Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in third line setting. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy
Measured: From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Mar 2024
- Primary completion28 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- 22,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557967
- Sponsor's protocol ID
- DS1062-0003-NIS-EPI
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Brain Metastases and Impact on Survival in Metastatic Non-small Cell Lung Cancer by Line of Treatment
- ClinicalTrials.gov ID
- NCT06557967
- Acronym / sponsor ID
- DS1062-0003-NIS-EPI
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Metastatic Cancer, Brain and Central Nervous System Cancer
- Keywords
- Real World Evidence, NSCLC, Brain metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,517 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 Aug 2024 (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.
This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes.
Detailed description
This retrospective cohort database study will generate real-world evidence describing prevalence of brain metastases at metastatic diagnosis and by line of therapy, patient characteristics, treatment patterns, and clinical outcomes in metastatic non-small cell lung cancer (mNSCLC) patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mNSCLC - Overall | – | Other: No drugParticipants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) |
| mNSCLC - 1st Line of Therapy | – | Other: No drugParticipants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in first line setting. |
| mNSCLC - 2nd Line of Therapy | – | Other: No drugParticipants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in second line setting. |
| mNSCLC - 3rd Line of Therapy | – | Other: No drugParticipants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in third line setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with metastatic NSCLC between 2015-2023 treated with systemic therapy.
Key inclusion criteria (6 listed)
- Diagnosis of mNSCLC in study period (01/01/2015-06/30/2023) including newly diagnosed at metastatic stage or progression from advanced stage NSCLC
- Age 18+ years at the time of diagnosis of mNSCLC
- Treated with systemic anti-cancer therapy in 1L setting
- Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting
Key exclusion criteria (2 listed)
- Evidence of other primary malignancy in the 365-day baseline period immediately prior to the first mNSCLC diagnosis in the study period
- Evidence of stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), or whole brain radiotherapy (WBRT) in the baseline period
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 |
|---|---|---|
| No drugThis is a non-interventional study and no study drug will be provided. | Other | mNSCLC - 1st Line of Therapy, mNSCLC - 2nd Line of Therapy, mNSCLC - 3rd Line of Therapy, mNSCLC - Overall |
Primary outcome
Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy
Time frame: From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.
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 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Lung Cancer, run by Daiichi Sankyo at 1 site in United States.
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 6 inclusion and 2 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 9 Dec 2024. 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 United States. 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?
Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy (time frame: From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.