Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
Completed
Conditions studied: Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06675695
- Run by
- Brigham and Women's Hospital
- People needed
- 4864
- Starts
- 2024-10-30
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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