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Clinical Trials in Non-Small Cell Lung Cancer with Biomarker-Driven Treatment Allocation: Ready or Not, Here We Come
Journal article   Open access   Peer reviewed

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

Edward B Garon, Phillip A Abarca, Jennifer L Strunck, Danielle Nameth, Catherine Neumann, Brian Wolf, Kevin Y Kim, Caitlin Marx and Robert M Elashoff
Critical reviews in oncogenesis, Vol.20(5-6), pp.339-348
2015
DOI: 10.1615/CritRevOncog.v20.i5-6.70
PMCID: PMC5273860
PMID: 27279233
url
https://www.ncbi.nlm.nih.gov/pmc/articles/5273860View
Open Access

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.
Biomarkers, Tumor - genetics Carcinoma, Non-Small-Cell Lung - diagnosis Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - metabolism Carcinoma, Non-Small-Cell Lung - therapy Clinical Trials as Topic Humans Lung Neoplasms - diagnosis Lung Neoplasms - genetics Lung Neoplasms - metabolism Lung Neoplasms - therapy Mutation Receptor, Epidermal Growth Factor - genetics

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