title: Clinician Perspectives on Current Issues in Lung Cancer Drug Development.
abstract: Recent advances in molecularly targeted therapy and immunotherapy offer a glimmer of hope for potentially realizing the dream of personalized therapy for lung cancer. This article highlights current questions in clinical trial design, enrollment strategies and patient focused drug development, with particular emphasis on unique issues in trials of targeted therapy and immunotherapy.
authors.affiliation: Division of Oncology, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Saiama N
authors.initials: SN
authors.lastname: Waqar
authors.affiliation: Rush University Medical Center, Chicago, Illinois.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Bonomi
authors.affiliation: Division of Oncology, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
authors.affiliation: University of Colorado Cancer Center, Denver, Colorado.
authors.forename: Fred R
authors.initials: FR
authors.lastname: Hirsch
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Riely
authors.affiliation: The University of Texas M. D. Anderson Cancer Center, Houston, Texas.
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Papadimitrakopoulou
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Dickran
authors.initials: D
authors.lastname: Kazandjian
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Sean
authors.initials: S
authors.lastname: Khozin
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Erin
authors.initials: E
authors.lastname: Larkins
authors.affiliation: Oregon Health and Science University, Portland, Oregon.
authors.forename: Dane J
authors.initials: DJ
authors.lastname: Dickson
authors.affiliation: National Cancer Institute, Bethesda, Maryland.
authors.forename: Shakun
authors.initials: S
authors.lastname: Malik
authors.affiliation: Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Leora
authors.initials: L
authors.lastname: Horn
authors.affiliation: LUNGevity Foundation, Bethesda, Maryland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ferris
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
authors.forename: Alice T
authors.initials: AT
authors.lastname: Shaw
authors.affiliation: Dana Farber Cancer Institute, Boston, Massachusetts.
authors.forename: Pasi A
authors.initials: PA
authors.lastname: Jänne
authors.affiliation: The Chinese University of Hong Kong, Hong Kong, People's Republic of China.
authors.forename: Tony S K
authors.initials: TS
authors.lastname: Mok
authors.affiliation: Yale School of Medicine, New Haven, Connecticut.
authors.forename: Roy
authors.initials: R
authors.lastname: Herbst
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Patricia
authors.initials: P
authors.lastname: Keegan
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland. Electronic address: Gideon.Blumenthal@fda.hhs.gov.
authors.forename: Gideon M
authors.initials: GM
authors.lastname: Blumenthal
mesh_terms: D060890:B7-H1 Antigen / Q000032:analysis / Q000037:antagonists & inhibitors; D002986:Clinical Trials as Topic; D018572:Disease-Free Survival; D055808:Drug Discovery; D066246:ErbB Receptors / Q000235:genetics; D006801:Humans; D007167:Immunotherapy; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D058990:Molecular Targeted Therapy; D009154:Mutation; D012107:Research Design
chemical_list: D060890:B7-H1 Antigen; D066246:ErbB Receptors
keywords: Clinical trials; Immunotherapy; Lung cancer; Targeted therapy