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

Daiichi Sankyo

Status: Active, not recruiting

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

Treatments: Other: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06557967

DS1062-0003-NIS-EPI

Details and patient eligibility

About

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.

Full 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

Enrollment: 22,517 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

22,517 participants in 4 patient groups

mNSCLC - Overall

Description:

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

Treatment:

Other: No drug

mNSCLC - 1st Line of Therapy

Description:

Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in first line setting.

Treatment:

Other: No drug

mNSCLC - 2nd Line of Therapy

Description:

Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in second line setting.

Treatment:

Other: No drug

mNSCLC - 3rd Line of Therapy

Description:

Participants with diagnosis of mNSCLC during study period (01/01/2015-06/30/2023) treated with systemic anti-cancer therapy in third line setting.

Treatment:

Other: No drug