Surrogate clinical endpoints to predict overall survival in non-small cell lung cancer trials-are we in a new era?

Journal Article (Journal Article)

Surrogate endpoints for clinical trials in oncology offer an alternative metric for measuring clinical benefit, allowing for shorter trial duration, smaller patient cohorts, and single arm design. The correlation of surrogate endpoints with overall survival (OS) in therapeutic studies is a central consideration to their validity. The Food and Drug Administration (FDA) recently published an analysis of fourteen clinical trials in advanced non-small cell lung cancer (NSCLC), and discovered a strong association between response rate and progression free survival. Furthermore, a correlation between response rate and OS is demonstrated when analyzing the experimental treatment arm separately, minimizing bias from patient crossover. We also highlight multiple, important considerations when using response as an endpoint in clinical trials involving NSCLC patients.

Full Text

Duke Authors

Cited Authors

  • Clarke, JM; Wang, X; Ready, NE

Published Date

  • December 2015

Published In

Volume / Issue

  • 4 / 6

Start / End Page

  • 804 - 808

PubMed ID

  • 26798592

Pubmed Central ID

  • PMC4700223

International Standard Serial Number (ISSN)

  • 2218-6751

Digital Object Identifier (DOI)

  • 10.3978/j.issn.2218-6751.2015.05.03


  • eng

Conference Location

  • China