2023
Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. Nature Medicine 2023, 29: 1718-1727. PMID: 37429923, DOI: 10.1038/s41591-023-02385-6.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerCell lung cancerSafety profileCombination therapyLung cancerInvestigator-assessed objective response rateRandomized phase 2 studySolid Tumors version 1.1T-cell-inflamed gene expression profileGroup IIIBiomarker-defined subgroupsFirst-line pembrolizumabPhase 2 studyProgression-free survivalResponse Evaluation CriteriaSubset of patientsHeterogenous tumor microenvironmentData cutoffOverall survivalSecondary outcomesPrimary outcomeTreatment armsTMB assessmentNovel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG).
Lee S, Fan W, Wang A, Vaidya R, Redman M, Gettinger S, Bazhenova L, Herbst R, Hershman D, Unger J. Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG). JCO Clinical Cancer Informatics 2023, 7: e2200165. PMID: 37084329, PMCID: PMC10281446, DOI: 10.1200/cci.22.00165.Peer-Reviewed Original ResearchConceptsSystem organ classAdverse event dataRandomized phase III trialPhase III trialsCell lung cancerOncology clinical trialsOverall toxicity profileIII trialsNeurologic toxicityTreatment armsCardiac toxicityLung cancerClinical trialsGrade 3High prevalenceOrgan classToxicity profileNivolumabTreatment groupsStage IVEndocrine toxicityType of AEToxicity typesAE termsIpilimumab
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
2010
Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials
Zinner RG, Novello S, Peng G, Herbst R, Obasaju C, Scagliotti G. Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials. Clinical Lung Cancer 2010, 11: 126-131. PMID: 20199979, DOI: 10.3816/clc.2010.n.017.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedMulticenter Studies as TopicNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPemetrexedRetrospective StudiesSurvival RateTreatment OutcomeConceptsNonsquamous histologyProgression-free survivalSquamous histologyOverall survivalLung cancerStage IIIB/IV non-small cell lung cancerResponse rateStage IIIB/IV NSCLCNon-small cell lung cancerRecent phase III studyPemetrexed-treated patientsChemotherapy-naive patientsPhase II studyPhase II trialPhase III studyCell lung cancerCarboplatin areaNSCLC histologyPlatinum doubletsII trialPrimary endpointII studyIII studyPerformance statusTreatment arms
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
2002
Safety and pharmacokinetic effects of TNP-470, an angiogenesis inhibitor, combined with paclitaxel in patients with solid tumors: evidence for activity in non-small-cell lung cancer.
Herbst RS, Madden TL, Tran HT, Blumenschein GR, Meyers CA, Seabrooke LF, Khuri FR, Puduvalli VK, Allgood V, Fritsche HA, Hinton L, Newman RA, Crane EA, Fossella FV, Dordal M, Goodin T, Hong WK. Safety and pharmacokinetic effects of TNP-470, an angiogenesis inhibitor, combined with paclitaxel in patients with solid tumors: evidence for activity in non-small-cell lung cancer. Journal Of Clinical Oncology 2002, 20: 4440-7. PMID: 12431966, DOI: 10.1200/jco.2002.04.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibiotics, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCyclohexanesDrug Administration ScheduleFemaleHumansLung NeoplasmsMaleMiddle AgedO-(Chloroacetylcarbamoyl)fumagillolPaclitaxelSesquiterpenesTreatment OutcomeConceptsTNP-470Solid tumorsPharmacokinetic interactionsOptimal doseAntiangiogenic agent TNP-470Minimal pharmacokinetic interactionsNeuropsychiatric test resultsSingle-agent doseMaximum-tolerated doseDoses of paclitaxelCell lung cancerPaclitaxel dosePrior chemotherapyChemotherapy regimensCombination regimenMedian survivalPartial responseArm AArm BPaclitaxel clearanceTreatment armsCytotoxic therapyLung cancerPharmacokinetic effectsPreclinical studies