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CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4]

NCT06585189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 304

Last updated 2024-09-05

No results posted yet for this study

Summary

The goal of this non-interventional study is to emulate the KEYNOTE-189 randomized controlled trial of pembrolizumab for the treatment of metastatic non-small cell lung cancer using real-world, electronic health record data. The main questions this study aims to answer are:

1. Do patients with metastatic non-small cell lung cancer (NSCLC) treated with pemetrexed, cisplatin/carboplatin, and pembrolizumab have improved real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) compared with patients treated with pemetrexed and cisplatin/carboplatin alone?
2. How do the results of this non-interventional study compare to those of the KEYNOTE-189 randomized controlled trial?

Conditions

Interventions

DRUG

Pembrolizumab

DRUG

Pemetrexed

DRUG

Cisplatin

DRUG

Carboplatin

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Janssen, LP

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Aetion, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2023-04-13
Completion
2023-04-13
FDA Drug
Yes

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Entities

Drugs
Diseases
Companies

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 NCT06585189 on ClinicalTrials.gov