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 A.
AU - Mandrekar, Sumithra J.
N1 - Publisher Copyright:
© 2018 International Association for the Study of Lung Cancer
PY - 2018/11
Y1 - 2018/11
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
C2 - 30194034
AN - SCOPUS:85055265497
SN - 1556-0864
VL - 13
SP - 1625
EP - 1637
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 11
ER -