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

Completed

• Conditions: Non-small Cell Lung Cancer; Metastatic Cancer; Lung Cancer; Brain and Central Nervous System Cancer
• Interventions: Other: No drug

• Registration Number: NCT06557967
• Lead Sponsor: Daiichi Sankyo

Brief 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.

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 Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-06-28
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-16
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22517

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mNSCLC - Overall	No drug	Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023)
mNSCLC - 1st Line of Therapy	No drug	Participants 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	No drug	Participants 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	No drug	Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in third line setting.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy	From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.

Trial Locations

Locations (1)

ConcertAI Database; 🇺🇸 Cambridge, Massachusetts, United States