Biomarker Clinical Trials in Lung Cancer

Design, Logistics, Challenges, and Practical Considerations

Jennifer Le-Rademacher, Suzanne Dahlberg, J. Jack Lee, Alex Adjei, Sumithra J Mandrekar

Research output: Contribution to journalReview article

2 Citations (Scopus)

Abstract

Treatment for lung cancer has evolved in the past 3 decades starting with platinum-based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker-driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early-phase biomarker discovery to proof-of-concept trials to definitive trials. We also present some thoughts on future directions.

Original languageEnglish (US)
Pages (from-to)1625-1637
Number of pages13
JournalJournal of Thoracic Oncology
Volume13
Issue number11
DOIs
StatePublished - Nov 1 2018

Fingerprint

Lung Neoplasms
Biomarkers
Clinical Trials
Precision Medicine
Standard of Care
Platinum
Histology
Therapeutics
Drug Therapy
Pharmaceutical Preparations
Direction compound

Keywords

  • Biomarker designs
  • Clinical trials
  • Logistical challenges
  • Lung cancer
  • Practical considerations

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Biomarker Clinical Trials in Lung Cancer : Design, Logistics, Challenges, and Practical Considerations. / Le-Rademacher, Jennifer; Dahlberg, Suzanne; Lee, J. Jack; Adjei, Alex; Mandrekar, Sumithra J.

In: Journal of Thoracic Oncology, Vol. 13, No. 11, 01.11.2018, p. 1625-1637.

Research output: Contribution to journalReview article

@article{e90bd29083b64cbba2e8308067d93438,
title = "Biomarker Clinical Trials in Lung Cancer: Design, Logistics, Challenges, and Practical Considerations",
abstract = "Treatment for lung cancer has evolved in the past 3 decades starting with platinum-based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker-driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early-phase biomarker discovery to proof-of-concept trials to definitive trials. We also present some thoughts on future directions.",
keywords = "Biomarker designs, Clinical trials, Logistical challenges, Lung cancer, Practical considerations",
author = "Jennifer Le-Rademacher and Suzanne Dahlberg and Lee, {J. Jack} and Alex Adjei and Mandrekar, {Sumithra J}",
year = "2018",
month = "11",
day = "1",
doi = "10.1016/j.jtho.2018.08.2019",
language = "English (US)",
volume = "13",
pages = "1625--1637",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "11",

}

TY - JOUR

T1 - Biomarker Clinical Trials in Lung Cancer

T2 - Design, Logistics, Challenges, and Practical Considerations

AU - Le-Rademacher, Jennifer

AU - Dahlberg, Suzanne

AU - Lee, J. Jack

AU - Adjei, Alex

AU - Mandrekar, Sumithra J

PY - 2018/11/1

Y1 - 2018/11/1

N2 - Treatment for lung cancer has evolved in the past 3 decades starting with platinum-based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker-driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early-phase biomarker discovery to proof-of-concept trials to definitive trials. We also present some thoughts on future directions.

AB - Treatment for lung cancer has evolved in the past 3 decades starting with platinum-based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker-driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early-phase biomarker discovery to proof-of-concept trials to definitive trials. We also present some thoughts on future directions.

KW - Biomarker designs

KW - Clinical trials

KW - Logistical challenges

KW - Lung cancer

KW - Practical considerations

UR - http://www.scopus.com/inward/record.url?scp=85055265497&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055265497&partnerID=8YFLogxK

U2 - 10.1016/j.jtho.2018.08.2019

DO - 10.1016/j.jtho.2018.08.2019

M3 - Review article

VL - 13

SP - 1625

EP - 1637

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 11

ER -