2015
355TiP Phase III clinical trials of atezolizumab compared with standard chemotherapy in PD-L1–selected chemotherapy-naïve patients with advanced NSCLC
Herbst R, de Marinis F, Jassem J, Spigel D, Shankar G, Mocci S, Sandler A, Lopez-Chavez A, Li S, Giaccone G. 355TiP Phase III clinical trials of atezolizumab compared with standard chemotherapy in PD-L1–selected chemotherapy-naïve patients with advanced NSCLC. Annals Of Oncology 2015, 26: ix103. DOI: 10.1093/annonc/mdv528.12.Peer-Reviewed Original ResearchA retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer 2015, 15: 171. PMID: 25881079, PMCID: PMC4412099, DOI: 10.1186/s12885-015-1146-8.Peer-Reviewed Original ResearchConceptsGene copy number gainCopy number gainsRET rearrangementsTumor samplesComparator armVandetanib treatmentNumber gainRandomized phase III studyPhase III clinical trialsCell lung cancer trialsObjective response ratePhase III studyLung cancer trialsRET protein expressionNSCLC subpopulationVandetanib armRadiologic evidenceIII studyNSCLC patientsObjective responseTumor shrinkageComparator drugsCancer trialsClinical trialsRetrospective analysis
2012
Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819
Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR. Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819. Clinical Cancer Research 2012, 18: 4004-4012. PMID: 22592956, PMCID: PMC3409929, DOI: 10.1158/1078-0432.ccr-12-0167.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabClinical Trials, Phase III as TopicDisease-Free SurvivalErbB ReceptorsHumansIn Situ Hybridization, FluorescenceLung NeoplasmsPrognosisProspective StudiesResearch DesignTreatment OutcomeConceptsNon-small cell lung cancerEpidermal growth factor receptorPredictive biomarkersStudy populationAdvanced non-small cell lung cancerEGFR FISH-positive patientsPhase III clinical trialsRole of cetuximabOverall study populationPhase III trialsCell lung cancerEntire study populationFISH-positive patientsInterim monitoring planGrowth factor receptorCoprimary endpointsIII trialsCetuximab efficacyLung cancerClinical trialsPositive groupCetuximabEGFR FISHFactor receptorMolecular targets
2010
Chemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase III Trial
Lu C, Lee JJ, Komaki R, Herbst RS, Feng L, Evans WK, Choy H, Desjardins P, Esparaz BT, Truong MT, Saxman S, Kelaghan J, Bleyer A, Fisch MJ. Chemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase III Trial. Journal Of The National Cancer Institute 2010, 102: 859-865. PMID: 20505152, PMCID: PMC2902826, DOI: 10.1093/jnci/djq179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBiological ProductsCarcinoma, Non-Small-Cell LungCartilageChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm StagingRadiotherapy, AdjuvantTissue ExtractsTreatment OutcomeConceptsNon-small cell lung cancerStage III non-small cell lung cancerUnresectable stage III non-small cell lung cancerProgression-free survivalTumor response rateCell lung cancerOverall survivalAE-941Lung cancerPlacebo groupClinical trialsUnresectable stage III NSCLC patientsResponse rateStage III NSCLC patientsPhase III clinical trialsAcademic oncology centerCommon grade 3Kaplan-Meier methodPhase III trialsShark cartilage extractTarget sample sizeToxic effectsChest radiotherapyConcurrent chemotherapyEligible patients
2009
Beyond Doublet Chemotherapy for Advanced Non–Small-Cell Lung Cancer: Combination of Targeted Agents with First-Line Chemotherapy
Herbst RS, Lynch TJ, Sandler AB. Beyond Doublet Chemotherapy for Advanced Non–Small-Cell Lung Cancer: Combination of Targeted Agents with First-Line Chemotherapy. Clinical Lung Cancer 2009, 10: 20-27. PMID: 19289368, DOI: 10.3816/clc.2009.n.003.Peer-Reviewed Original ResearchConceptsBest supportive careOverall survivalMetastatic NSCLCLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerPhase III clinical trialsPlatinum-based doubletsAddition of bevacizumabFirst-line chemotherapyPlatinum-based regimensProgression-free survivalFirst-line treatmentCell lung cancerOverall patient survivalTyrosine kinase inhibitorsInhibition of componentsMatrix metalloproteinase inhibitorsDoublet chemotherapySystemic chemotherapyMedian survivalSupportive careMost patientsTargeted agentsChemotherapeutic regimens