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Trial Title:
Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment
NCT ID:
NCT06557967
Condition:
Non-small Cell Lung Cancer
Lung Cancer
Metastatic Cancer
Brain and Central Nervous System Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Conditions: Keywords:
Real World Evidence
NSCLC
Brain metastases
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
No drug
Description:
This is a non-interventional study and no study drug will be provided.
Arm group label:
mNSCLC - 1st Line of Therapy
Arm group label:
mNSCLC - 2nd Line of Therapy
Arm group label:
mNSCLC - 3rd Line of Therapy
Arm group label:
mNSCLC - Overall
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
Criteria for eligibility:
Study pop:
Participants diagnosed with metastatic NSCLC between 2015-2023 treated with systemic
therapy.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ConcertAI Database
Address:
City:
Cambridge
Zip:
02138
Country:
United States
Start date:
March 1, 2024
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06557967
