Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials 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 12 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv2
  3. 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.
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 NCT07485166
Lead Sponsor Brigham and Women's Hospital
Collaborators: Food and Drug Administration (FDA)
Conditions
(from sponsor)		 Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non Small Cell Lung Cancer
Enrollment 810 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov