Study on Prevalence and Impact of Brain Metastases on Survival in 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.

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Key information

Conditions

Non-small Cell Lung Cancer Brain Diseases Brain Neoplasms Brain and Central Nervous System Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ConcertAI Database

Cambridge, Massachusetts, 02138, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No drug

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Prevalence of Brain Metastases and Impact on Survival in Metastatic Non-small Cell Lung Cancer by Line of Treatment

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 16, 2024
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed