Emulation of the KEYNOTE-042 (NCT02220894) Trial Using Specialty Oncology Electronic Health Records Databases

StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Sep 12, 2026 → Mar 12, 2027
See other at-risk trials from Brigham and Women's Hospital

Record History

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  1. Primary completion pushed from Sep 12, 2026 to Mar 12, 2027
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Eligibility criteria expanded, about 17 words
    • Site details revised
  2. Study description expanded, about 1 wordv3
  3. Study description expanded, about 52 words
    • Eligibility criteria expanded, about 2 words
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07485179
Lead Sponsor Brigham and Women's Hospital
Collaborators: Food and Drug Administration (FDA)
Conditions
(from sponsor)		 Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 770 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov