Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases

Study summary

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNew use of osimertinib and New use of erlotinib or gefitinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 30, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Brigham and Women's Hospital

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Brigham and Women's Hospital
Interventions being studied: Drug: New use of osimertinib; Drug: New use of erlotinib or gefitinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Market availability of osimertinib began April 18, 2018. Study Period: ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 2 (EDB2): Follow-up information through 02/24/2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023.
Age \>= 18
New users of first-line antineoplastic system therapy: osimertinib, gefitinib, or erlotinib for advanced/metastatic disease
Mention of 'adenocarcinoma' histology ('non-squamous' in EDB1)
Line of therapy setting needs to be 'advanced' (EDB1), 'metastatic' (EDB2) or there needs to be evidence of metastatic disease at time of treatment initiation (EDB4)
Evidence of any EGFR mutation in the 180 days before/on treatment initiation
Treatment needs to be first-line for advanced (EDB1) or metastatic (EDB2) disease or patients with prior exposure to any potential antineoplastic treatment commonly used in the advanced/metastatic NSCLC setting are excluded (EDB4)
ECOG 0 or 1 in the 90 days before/on treatment initiation

Reasons someone may not be able to joinExclusion criteria

Missing age
Concurrent primary malignancies (EDB2)
Missing date of diagnosis or clinician note in the EHR (EDB2)
Only one visit at provider site (EDB2)
Metastatic (includes leukemias and multiple myeloma) for a malignancy diagnosed prior to the malignancy of interest with the presence of low grade (inclusive of grades 1 and 2) neuroendocrine histology (EDB2)
Participation in any clinical trial at any point in treatment history (EDB4)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Brigham and Women's HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 30, 2026. Always confirm current availability with the study team.

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