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

NCT07485166 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 810

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Initiation of nivolumab

Initiation of nivolumab described in electronic health records is used as the exposure.

DRUG

Initiation of docetaxel

Initiation of docetaxel described in electronic health records is used as the reference.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2026-09-12
Completion
2027-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485166 on ClinicalTrials.gov