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Critical Reviews™ in Oncogenesis
SJR: 0.631 SNIP: 0.503 CiteScore™: 2

ISSN Print: 0893-9675
ISSN Online: 2162-6448

Critical Reviews™ in Oncogenesis

DOI: 10.1615/CritRevOncog.v20.i5-6.70
pages 339-347

Clinical Trials in Non-Small Cell Lung Cancer with Biomarker-Driven Treatment Allocation: Ready or Not, Here We Come

Edward B. Garon
Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA
Phillip A. Abarca
Keck School of Medicine of USC, Los Angeles, CA
Jennifer L. Strunck
Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA
Danielle Nameth
Tufts University School of Medicine, Boston, MA
Catherine Neumann
Boston University School of Medicine, Boston, MA
Brian Wolf
Sackler Faculty of Medicine at Tel Aviv University, Tel Aviv, Israel
Kevin Y. Kim
Loma Linda University School of Medicine, Loma Linda, CA
Caitlin Marx
Oregan Health and Sciences University, OHSU Knight Cancer Institute, Portland, OR
Robert M. Elashoff
Department of Biostatistics, Fielding School of Public Health at UCLA, Los Angeles, CA

ABSTRACT

Lung cancer is the leading cause of cancer mortality. Great advances in non-small cell lung cancer therapy have been seen in the last decade, beginning with the success in treating lung cancer harboring EGFR mutations and ALK-gene rearrangements. The potential of these biomarker-driven therapies has propelled research in biomarker targeted approaches to the forefront of lung cancer research. The successful development of immunotherapeutic agents targeting PD-L1 and PD-1 with an associated non-genomic biomarker has opened a new front in the effort for targeted approaches. Although early-phase lung cancer studies have hinted at the potential to use biomarkers to select patients for allocation to treatment in the conduct of clinical trials, data from late-phase studies have tempered expectations. The data leave unclear the wisdom of routinely restricting enrollment on lung cancer clinical trials to biomarker restricted populations, particularly non-genomic biomarkers.