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

Part of paid clinical trials in Somerville, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07485179
Status
Active Not Recruiting

Conditions

  • Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Initiation of pembrolizumab — DRUG
    Initiation of pembrolizumab (IV infusion) described in electronic health records is used as the exposure.
  • Initiation of chemotherapy — DRUG
    Initiation of chemotherapy (carboplatin plus paclitaxel or pemetrexed for 4-6 cycles) 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
770 participants (estimated)

Arms

  • Arm: Initiation of pembrolizumab
    Exposure group
  • Arm: Initiation of chemotherapy
    Reference group

Primary Outcome Measure

Overall survival [OS] - Time to all-cause mortality (OS) [ Time Frame: Time from the end of the treatment assessment window defined by the vendor's business rules to identify the line of therapy until the earliest of outcome, censoring, or end of data availability ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalSomervilleMassachusetts02145-

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