Novel Clinical Trial Designs for Metastatic Lung Cancer

Vassiliki A. Papadimitrakopoulou

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The landscape of nonsmall cell lung cancer (NSCLC) treatment was significantly affected by the novel paradigm of successfully pairing biomarker-defined cohorts of patients with targeted therapeutics such as EGFR mutations as biomarkers of benefit from epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) and EML-ALK translocations and ALK TKIs. This has led to substantial enthusiasm about following this paradigm for rapid development of novel therapeutics. Despite increased investment in research and development, the path to marketing authorization of new drugs remains challenging, and occasionally inefficient. Novel approaches to clinical development and trial design could be crucial in overcoming some of these challenges. Adaptive clinical trials have the advantage of testing several biomarker hypotheses within a single clinical trial, a model that increases flexibility and maximizes the use of accumulated knowledge. Two notable examples of this approach are the BATTLE study in lung cancer and ISPY-2 in breast cancer patients. Advantages and challenges of this trial methodology along with other aspects of clinical trials are discussed in this chapter.

Original languageEnglish (US)
Title of host publicationLung Cancer
Subtitle of host publicationFourth Edition
PublisherWiley-Blackwell
Pages479-487
Number of pages9
ISBN (Electronic)9781118468791
ISBN (Print)9781118468746
DOIs
StatePublished - May 27 2014

Keywords

  • Adaptive clinical trial designs
  • Biomarkers
  • Novel therapeutics

ASJC Scopus subject areas

  • General Medicine

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