2022
Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)
Atkins MB, Abu-Sbeih H, Ascierto PA, Bishop MR, Chen DS, Dhodapkar M, Emens LA, Ernstoff MS, Ferris RL, Greten TF, Gulley JL, Herbst RS, Humphrey RW, Larkin J, Margolin KA, Mazzarella L, Ramalingam SS, Regan MM, Rini BI, Sznol M. Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). Journal For ImmunoTherapy Of Cancer 2022, 10: e005413. PMID: 36175037, PMCID: PMC9528604, DOI: 10.1136/jitc-2022-005413.Peer-Reviewed Original ResearchConceptsPhase III trialsImmunotherapy of cancerIII trialsCurative responseImmune checkpoint inhibitor monotherapyCell death protein 1Checkpoint inhibitor monotherapyDefinitive predictive biomarkersDurable clinical benefitProgression-free survivalMinority of patientsDeath protein 1Variety of indicationsClinical trial designAnimal tumor modelsLimited Phase IDrug development programsImmunotherapy combinationsInvestigational chemotherapyImmunotherapy fieldInhibitor monotherapyOverall survivalDismal prognosisClinical benefitSurvival outcomesESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer
Passaro A, Leighl N, Blackhall F, Popat S, Kerr K, Ahn M, Arcila M, Arrieta O, Planchard D, de Marinis F, Dingemans A, Dziadziuszko R, Faivre-Finn C, Feldman J, Felip E, Curigliano G, Herbst R, Jänne P, John T, Mitsudomi T, Mok T, Normanno N, Paz-Ares L, Ramalingam S, Sequist L, Vansteenkiste J, Wistuba I, Wolf J, Wu Y, Yang S, Yang J, Yatabe Y, Pentheroudakis G, Peters S. ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer. Annals Of Oncology 2022, 33: 466-487. PMID: 35176458, DOI: 10.1016/j.annonc.2022.02.003.Peer-Reviewed Original ResearchConceptsCell lung cancerLung cancerESMO Clinical Practice GuidelinesManagement of EGFRClinical practice guidelinesExpert consensus statementClinical trial designSummary of evidenceEpidermal growth factor receptorGrowth factor receptorAdvanced diseaseMetastatic diseaseMedical oncologyConsensus statementMultidisciplinary panelPractice guidelinesConsensus recommendationsTrial designExpert panel discussionAvailable evidenceEuropean SocietyFactor receptorCancerExpert panelBiomarker analysis
2019
Challenges and approaches to implementing master/basket trials in oncology
Burd A, Schilsky RL, Byrd JC, Levine RL, Papadimitrakopoulou VA, Herbst RS, Redman MW, Druker BJ, Gandara DR. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 2019, 3: 2237-2243. PMID: 31337605, PMCID: PMC6650731, DOI: 10.1182/bloodadvances.2019031229.Peer-Reviewed Original ResearchConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetite
2018
60 How to Promote and Organize Clinical Research in Lung Cancer
Barlesi F, Mazieres J, Zhou Y, Herbst R, Zalcman G. 60 How to Promote and Organize Clinical Research in Lung Cancer. 2018, 628-634.e2. DOI: 10.1016/b978-0-323-52357-8.00060-3.Peer-Reviewed Original ResearchLung cancerClinical trialsNew clinical trial designsClinical trial designPotential therapeutic drugBasic science dataClinical researchersAppropriate trialsPreclinical dataPreventative optionsCertain therapiesTrial designNew treatmentsClinical researchPreclinical conceptsTherapeutic drugsCancerTrialsPatientsPersonalized medicineTherapyBiomarkers
2016
Clinician Perspectives on Current Issues in Lung Cancer Drug Development
Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM. Clinician Perspectives on Current Issues in Lung Cancer Drug Development. Journal Of Thoracic Oncology 2016, 11: 1387-1396. PMID: 27401214, PMCID: PMC5131641, DOI: 10.1016/j.jtho.2016.05.009.Peer-Reviewed Original Research
2015
Lung-MAP—framework, overview, and design principles
Ferrarotto R, Redman MW, Gandara DR, Herbst RS, Papadimitrakopoulou VA. Lung-MAP—framework, overview, and design principles. Chinese Clinical Oncology 2015, 4: 36-36. PMID: 26408303, DOI: 10.3978/j.issn.2304-3865.2015.09.02.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaLung-MAPClinical trialsMetastatic lung squamous cell carcinomaLung squamous cell carcinomaLung SCC patientsLimited therapeutic optionsEvidence of efficacyPoor patient outcomesClinical trial designDriver genetic alterationsEligible patientsSCC patientsPatients' qualityTreatment armsTherapeutic optionsCell carcinomaTherapy clinical trialsPatient outcomesTrial designMaster protocolsPatientsFDA approvalGenomic profilingPromising agent
2007
A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine
Zhou X, Kim E, Herbst R, Liu S, Wistuba I, Mao L, Lewis J, Lippman S, Hong W, Lee J. A clinical trial design applying Bayesian adaptive randomization for targeted therapy development in lung cancer: A step toward personalized medicine. Journal Of Clinical Oncology 2007, 25: 7697-7697. DOI: 10.1200/jco.2007.25.18_suppl.7697.Peer-Reviewed Original ResearchBiomarker profilesEffective agentResponse rateRandomization ratesLung Cancer EliminationTumor biomarker profilesClinical trial designBayesian adaptive randomizationCancer ptsPrior chemotherapyTreatment armsClinical efficacyLung cancerCancer eliminationEffective therapyLung carcinogenesisTargeted therapyDifferent biomarker profilesTrial designTreatment efficacyBiopsy samplesTherapy trialsPatient entryBiomarker expressionTherapy