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

NCT06675695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4864

Last updated 2026-01-30

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

New use of osimertinib

New use of osimertinib described in electronic health records is used as the exposure.

DRUG

New use of erlotinib or gefitinib

New use of "standard of care" described in electronic health records (erlotinib or gefitinib) dispensing claim is used as the reference.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2025-11-01
Completion
2025-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06675695 on ClinicalTrials.gov