Clinical Trials in Non-Small Cell Lung Cancer with Biomarker-Driven Treatment Allocation: Ready or Not, Here We Come.
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.
Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA.
Edward B
EB
Garon
Keck School of Medicine of USC, Los Angeles, CA.
Phillip A
PA
Abarca
Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA.
Jennifer L
JL
Strunck
Tufts University School of Medicine, Boston, MA.
Danielle
D
Nameth
Boston University School of Medicine, Boston, MA.
Catherine
C
Neumann
Sackler Faculty of Medicine at Tel Aviv University, Tel Aviv, Israel.
Brian
B
Wolf
Loma Linda University School of Medicine, Loma Linda, CA.
Kevin Y
KY
Kim
Oregan Health and Sciences University, OHSU Knight Cancer Institute, Portland, OR.
Caitlin
C
Marx
Department of Biostatistics, Fielding School of Public Health at UCLA, Los Angeles, CA.
Robert M
RM
Elashoff
D014408:Biomarkers, Tumor / Q000235:genetics*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000235:genetics* / Q000378:metabolism / Q000628:therapy; D002986:Clinical Trials as Topic; D066246:ErbB Receptors / Q000235:genetics; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000378:metabolism / Q000628:therapy; D009154:Mutation
D014408:Biomarkers, Tumor; C512478:EGFR protein, human; D066246:ErbB Receptors