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

NCT06557967 | Completed

• 1 other identifier: DS1062-0003-NIS-EPI
• Study Type: observational
• Target: 22,517
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Real World Evidence; NSCLC; Brain metastases

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

mNSCLC - Overall

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

Other: No drug

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

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

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

Interventions

No drug OTHER

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

mNSCLC - 1st Line of Therapy; mNSCLC - 2nd Line of Therapy; mNSCLC - 3rd Line of Therapy; mNSCLC - Overall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Treated with systemic anti-cancer therapy in 1L setting
• Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

ConcertAI Database

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis; Central Nervous System Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: March 1, 2024
• Primary Completion: June 28, 2024
• Study Completion: September 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)