Clinical trial · Observational
Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
NCT06675695CI-TRIAL-00102101completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| New use of erlotinib or gefitinib | Drug | — | UNRESOLVED |
| New use of osimertinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- New use of osimertinib
- description
- Exposure group
- interventionNames
- Drug: New use of osimertinib
- label
- New use of erlotinib or gefitinib
- description
- Reference group
- interventionNames
- Drug: New use of erlotinib or gefitinib
Primary outcomes (1)
- measure
- Time to all-cause mortality (overall survival)
- timeFrame
- Through the earliest of outcome, censoring, or end of data (April 2024)
- description
- Hazard ratio (95% CI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.