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

December 6, 2024 updated by: Daiichi Sankyo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • ConcertAI Database

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with metastatic NSCLC between 2015-2023 treated with systemic therapy.

Description

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

    Additional inclusion criteria for 1st Line of Therapy cohort:

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

    Additional inclusion criteria for 2nd Line of Therapy and 3rd Line of Therapy cohorts:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mNSCLC - Overall
Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023)
Other: No drug
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.
Other: No drug
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.
Other: No drug
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.
Other: No drug
This is a non-interventional study and no study drug will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS1062-0003-NIS-EPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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