2023
Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Gray J, Redman M. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP). JCO Precision Oncology 2023, 7: e2300218. PMID: 37677122, PMCID: PMC10581630, DOI: 10.1200/po.23.00218.Peer-Reviewed Original ResearchConceptsCharacteristics of patientsLung-MAPMaster protocolsNSCLC populationCell lung cancer trialsSEER registry dataPatients 65 yearsPrecision medicine clinical trialsPatient exclusion criteriaLung cancer trialsRepresentativeness of patientsMedicine clinical trialsNSCLC trialsOlder patientsMedicaid/More patientsSubgroup analysisCancer trialsClinical trialsVulnerable patientsRegistry dataExclusion criteriaPatientsNSCLC studiesSociodemographic characteristics
2022
Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Redman M. Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP). Journal Of Clinical Oncology 2022, 40: 6543-6543. DOI: 10.1200/jco.2022.40.16_suppl.6543.Peer-Reviewed Original ResearchLung-MAPRepresentativeness of patientsNSCLC populationMaster protocolsNSCLC trialsMedicaid/National Clinical Trials NetworkNon-small cell lung cancer trialsSquamous cell lung cancerEnd Results registry dataNovel therapeuticsCell lung cancer trialsCell lung cancerLung cancer trialsClinical Trials NetworkNeighborhood socioeconomic deprivationArea-level measuresOlder patientsMore patientsHispanic patientsRural patientsTrial participationLung cancerTrial findingsCancer trials
2021
Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN)
Roth JA, Trivedi MS, Gray SW, Patrick DL, Delaney DM, Watabayashi K, Litwin P, Shah P, Crew KD, Yee M, Redman MW, Unger JM, Papadimitrakopoulou V, Johnson J, Kelly K, Gandara D, Herbst RS, Hershman DL, Ramsey SD. Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN). JCO Oncology Practice 2021, 17: e1821-e1829. PMID: 33797955, PMCID: PMC9810137, DOI: 10.1200/op.20.00770.Peer-Reviewed Original ResearchConceptsMaster protocolsPatient knowledgeCell lung cancerOncology clinical trialsMost participantsMaster protocol trialsMedian ageEligible participantsLung cancerLung-MAPClinical trialsOdds ratioGenomic resultsCancer riskProtocol trialSociodemographic factorsCancer treatmentPilot studyCancer diagnosisTelephone surveyRiskCorrect responsesDemographic factorsCancerDescriptive statistics
2020
Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. The Lancet Oncology 2020, 21: 1589-1601. PMID: 33125909, PMCID: PMC8109255, DOI: 10.1016/s1470-2045(20)30475-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Decision-MakingDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicinePredictive Value of TestsProgression-Free SurvivalTime FactorsYoung AdultConceptsCell lung cancerNational Cancer InstituteTargeted therapy groupLung cancerLung-MAPMaster protocolsDocetaxel groupTherapy groupEastern Cooperative Oncology Group performance statusUnmet needMedian progression-free survivalNational Clinical Trials NetworkMedian overall survivalAdvanced lung cancerProgression-free survivalPlatinum-based chemotherapyClinical Trials NetworkNational InstituteClinical trial componentUS National Cancer InstituteNew screening protocolBristol-Myers SquibbAdditional substudyEligible patientsImmunotherapy combinationsLung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC).
Redman M, Papadimitrakopoulou V, Minichiello K, Gandara D, Hirsch F, Mack P, Schwartz L, Vokes E, Ramalingam S, Leighl N, Bradley J, LeBlanc M, Malik S, Miller V, Sigal E, Adam S, Blanke C, Kelly K, Herbst R. Lung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC). Journal Of Clinical Oncology 2020, 38: 9576-9576. DOI: 10.1200/jco.2020.38.15_suppl.9576.Peer-Reviewed Original ResearchBiomarker-driven studiesLung-MAPNational Clinical Trials NetworkClinical Trials NetworkSquamous lung cancerNational Cancer InstituteLung cancerTherapy questionsCancer InstituteUnmet needSuccess of PDMaster protocolsTrials NetworkPatientsBiomarker resultsSqNSCLCRegulatory approvalTherapyDurvalumabIpilimumabNivolumabTrial partsFoundationOneNSCLCS1400
2019
A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952).
Bazhenova L, Redman M, Gettinger S, Hirsch F, Mack P, Schwartz L, Gandara D, Bradley J, Stinchcombe T, Leighl N, Ramalingam S, Tavernier S, Minichiello K, Kelly K, Papadimitrakopoulou V, Herbst R. A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952). Journal Of Clinical Oncology 2019, 37: 9014-9014. DOI: 10.1200/jco.2019.37.15_suppl.9014.Peer-Reviewed Original ResearchInvestigator-assessed progression-free survivalOverall survivalInterim analysisStage IV squamous cell lung cancerSquamous cell lung cancerGrade 5 AEsImmunotherapy-naïve patientsStudies of nivolumabTreatment-related AEsPD-L1 expressionProgression-free survivalPhase IIICell lung cancerECOG 0Primary endpointRECIST 1.1Baseline characteristicsPD-L1Lung cancerLung-MAPNivolumabStage IVPatientsResponse rateMaster protocols
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 agentInnovative Clinical Trials: The LUNG‐MAP Study
Steuer C, Papadimitrakopoulou V, Herbst R, Redman M, Hirsch F, Mack P, Ramalingam S, Gandara. Innovative Clinical Trials: The LUNG‐MAP Study. Clinical Pharmacology & Therapeutics 2015, 97: 488-491. PMID: 25676724, DOI: 10.1002/cpt.88.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicGenetic Predisposition to DiseaseGenomicsHumansLung NeoplasmsMolecular Targeted TherapyPhenotypePrecision MedicineResearch DesignSignal TransductionConceptsCell lung cancerSquamous cell carcinomaSquamous cell lung cancerCell carcinomaLung cancerTrial designNon-small cell lung cancerMetastatic squamous cell carcinomaSecond-line therapyProportion of patientsNew active drugsNovel trial designsDrug developmentWide molecular heterogeneityAdenocarcinoma histologyLine therapyTherapeutic optionsLung-MAPClinical trialsGroup trialsActive drugPatientsMaster protocolsCarcinomaCancerLung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400
Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA. Lung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400. Clinical Cancer Research 2015, 21: 1514-1524. PMID: 25680375, PMCID: PMC4654466, DOI: 10.1158/1078-0432.ccr-13-3473.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaLung squamous cell carcinomaMaster protocolsClinical trialsAdvanced lung squamous cell carcinomaSquamous cell lung cancerCell lung cancerStandard of careMutation/amplificationTraditional clinical trialsDevelopment of therapiesInvestigational agentsCell carcinomaLung cancerCancer Genome Atlas (TCGA) projectMolecular abnormalitiesTherapyLungTrialsSignificant numberCarcinomaCancerAbnormalitiesProtocolCare
2014
119IN Novel Molecular Studies to Inform the Conduct of Oncology Clinical Trials: from Battle to Master Protocols
Herbst R. 119IN Novel Molecular Studies to Inform the Conduct of Oncology Clinical Trials: from Battle to Master Protocols. Annals Of Oncology 2014, 25: iv41. DOI: 10.1093/annonc/mdu317.1.Peer-Reviewed Original ResearchLung cancer patientsCancer patientsSquamous cell lung cancer patientsMaster protocolsMulticenter phase 2 trialCell lung cancer patientsNovel molecular studiesPhase 2 trialScreen failure rateOncology clinical trialsCause of deathEffective treatment regimensIdentification of therapiesClinical trial researchIndividual patient's cancerSystemic chemotherapyClinical characteristicsMetastatic diseaseMost patientsPerformance statusTreatment regimensMultiple therapiesClinical trialsAdaptive randomization designPatient's cancer
2013
IS7–2 Personalized Therapy for Advanced Non-Small Cell Lung Cancer: From the Battle Trial to Master Protocols
Herbst R. IS7–2 Personalized Therapy for Advanced Non-Small Cell Lung Cancer: From the Battle Trial to Master Protocols. Annals Of Oncology 2013, 24: ix19. DOI: 10.1093/annonc/mdt447.2.Peer-Reviewed Original Research