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Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment

NCT ID: NCT06557967

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Non-small Cell Lung Cancer Lung Cancer Metastatic Cancer Brain and Central Nervous System Cancer

Keywords

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Real World Evidence NSCLC Brain metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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mNSCLC - Overall

Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023)

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

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.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

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.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

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.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

Interventions

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No drug

This is a non-interventional study and no study drug will be provided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of mNSCLC in study period (01/01/2015-06/30/2023) including newly diagnosed at metastatic stage or progression from advanced stage NSCLC
2. Age 18+ years at the time of diagnosis of mNSCLC

3. Treated with systemic anti-cancer therapy in 1L setting

4. Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting

Exclusion Criteria

1. Evidence of other primary malignancy in the 365-day baseline period immediately prior to the first mNSCLC diagnosis in the study period
2. Evidence of stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), or whole brain radiotherapy (WBRT) in the baseline period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ConcertAI Database

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DS1062-0003-NIS-EPI

Identifier Type: -

Identifier Source: org_study_id