Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases

Part of paid clinical trials in Somerville, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07485166
Status
Active Not Recruiting

Conditions

  • Advanced Non-squamous Non-small-cell Lung Cancer
  • Advanced Squamous Non Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Initiation of nivolumab — DRUG
    Initiation of nivolumab described in electronic health records is used as the exposure.
  • Initiation of docetaxel — DRUG
    Initiation of docetaxel described in electronic health records 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
Mar 12, 2026
Status verified
Feb 2026
Primary completion
Sep 12, 2026
Completion
Mar 12, 2027

Study Design

Enrollment
810 participants (estimated)

Arms

  • Arm: Initiation of nivolumab
    Exposure group
  • Arm: Initiation of docetaxel
    Reference group

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalSomervilleMassachusetts02145-

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