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

NCT07485179 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 770

Last updated 2026-05-12

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 or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Initiation of pembrolizumab

Initiation of pembrolizumab (IV infusion) described in electronic health records is used as the exposure.

DRUG

Initiation of chemotherapy

Initiation of chemotherapy (carboplatin plus paclitaxel or pemetrexed for 4-6 cycles) 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 NCT07485179 on ClinicalTrials.gov