Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
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.
Checked against the public recordLast updated Jan 30, 2026 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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. Inclusion Criteria: * 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 Exclusion 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.
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.