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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06675695
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Oct 30, 2024
Status verified
Nov 2024
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
4,864 participants (actual)

Arms

  • Arm: New use of osimertinib
    Exposure group
  • Arm: New use of erlotinib or gefitinib
    Reference group

Primary Outcome Measure

Time to all-cause mortality (overall survival) [ Time Frame: Through the earliest of outcome, censoring, or end of data (April 2024) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Brigham and Women's Hospital· Boston, MA

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