NCT05908799

Emulation of the KEYNOTE-189 Trial Using Electronic Health Records

Emulation of a Comparative Effectiveness Study of Pembrolizumab and Chemotherapy vs. Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,854 (actual)
• Sponsor: Aetion, Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Investigators are building an empirical evidence base supporting the utility of real-world data through the emulation of randomized controlled trials in the oncology setting. The purpose of this work is to demonstrate whether real-world evidence studies can provide reliable conclusions on treatment effectiveness to inform further applications of real-world data in pharmaceutical product label expansion, post-marketing safety, and other purposes that are complementary to RCTs.

Detailed description

This is a non-randomized observational study that is being conducted as a part of the Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative, a multi-stakeholder collaboration led by Aetion. The study is intended to emulate the trial listed below/above. Although many features of the trial cannot be directly replicated in real-world data sources, key elements of the study design, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial as closely as possible. Investigators assume that the trial provides the reference standard treatment effect estimate and that failure to replicate trial findings is indicative of the inadequacy of the real-world data source for replication for a range of possible reasons and does not provide information on the validity of the original trial finding.

Conditions

• Non-small Cell Lung Cancer
• Metastatic Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab + Pemetrexed-Platinum	Medication records in EHR database used to define exposure group
DRUG	Pemetrexed-Platinum	Medication records in EHR database used to define comparator group

Timeline

• Start date: 2023-06-05
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-06-18
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study