NCT06675695Completed
Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 4864 (actual)
- First submitted
- 1 Nov 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06675695
What you commit to
- Study type: Observational
- Participants enrolled: 4864
- From 30 Oct 2024 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent primary malignancies (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)
Age
- Missing age
Other
- Missing date of diagnosis or clinician note in the EHR (EDB2)
- Only one visit at provider site (EDB2)
- Participation in any clinical trial at any point in treatment history (EDB4)
Who the study is looking for
- 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
Criteria the registry did not label
- 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.