2024
Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).
Carrizosa D, Miao J, Reckamp K, Dragnev K, Hesketh P, Iams W, Henick B, Czerlanis C, DeSanto F, Sundstrom J, Johnson J, Gansauer L, Groller T, Redman M, Herbst R, Gray J. Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302). Journal Of Clinical Oncology 2024, 42: 11019-11019. DOI: 10.1200/jco.2024.42.16_suppl.11019.Peer-Reviewed Original ResearchRecruitment planTrial designClinical trial enrollmentAdvanced/metastatic NSCLCAccrual rateStandard therapyPatient education materialsImprove community awarenessPatient accrual rateSWOGClinical trialsTrial enrollmentVA sitesApproaches to trial designPatient advocatesPatientsDecrease barriersMinority accrualRecruitment strategiesAdvocacy partnersLatinx patientsCommunity awarenessTrialsEducational materialsEnrollment information
2022
635 KEYNOTE-495/KeyImPaCT: updated analysis of a biomarker-directed, randomized, phase 2 trial of pembrolizumab-based combination therapy for non-small cell lung cancer
Herbst R, Lam W, Hellmann M, Gubens M, Aggarwal C, Weng 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, Gutierrez M. 635 KEYNOTE-495/KeyImPaCT: updated analysis of a biomarker-directed, randomized, phase 2 trial of pembrolizumab-based combination therapy for non-small cell lung cancer. 2022, a666-a666. DOI: 10.1136/jitc-2022-sitc2022.0635.Peer-Reviewed Original ResearchBFAST but be smart: bTMB remains an exploratory biomarker in NSCLC
Kim SY, Herbst RS. BFAST but be smart: bTMB remains an exploratory biomarker in NSCLC. Nature Reviews Clinical Oncology 2022, 20: 3-4. PMID: 36271141, DOI: 10.1038/s41571-022-00698-y.Peer-Reviewed Original ResearchConceptsCell lung cancerTumor mutational burdenLung cancerMutational burdenBlood-based tumor mutational burdenAdvanced-stage solid tumorsFirst phase III trialHigh tumor mutational burdenImmune checkpoint inhibitorsPhase III trialsIII trialsPredictive biomarkersExploratory biomarkersCompanion biomarkersSolid tumorsBiomarkersCancerBurdenPembrolizumabNSCLCPatientsTumorsTrialsWhen immunotherapy meets surgery in non-small cell lung cancer
Herbst RS, Wang M, Chen L. When immunotherapy meets surgery in non-small cell lung cancer. Cancer Cell 2022, 40: 603-605. PMID: 35660136, DOI: 10.1016/j.ccell.2022.05.010.Peer-Reviewed Original Research
2020
The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials
Tam AL, Papadimitrakopoulou V, Wistuba II, Lee JJ, Ensor JE, Kim ES, Kalhor N, Blumenschein GR, Tsao AS, Heymach JV, Herbst RS, Hicks ME, Hong WK, Gupta S. The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials. Clinical Radiology 2020, 76: 155.e25-155.e34. PMID: 33268083, DOI: 10.1016/j.crad.2020.09.024.Peer-Reviewed Original ResearchConceptsInterventional radiologistsClinical trial teamsTrial teamPercutaneous image-guided biopsyLung Cancer EliminationLung cancer trialsEvidence of viabilityImage-guided biopsyLesion scoring systemBiomarker analysisCancer trialsTargeted therapyCancer eliminationScore's abilityInterventional radiologyMultivariate analysisLesionsBiopsySolid massFollowing criteriaModerate agreementMultidisciplinary approachTrialsScoresBiomarkersIncreased tumor purity and improved biomarker detection using precision needle punch enrichment of pathology specimen paraffin blocks: Method validation and implementation in a prospective clinical trial.
Killian J, Wright C, Chan L, Danziger N, Elvin J, Vergilio J, Lin D, Williams E, Ramkissoon S, Severson E, Hemmerich A, Duncan D, Edgerly C, Tse J, McGregor K, Schrock A, Alexander B, Ross J, Redman M, Herbst R. Increased tumor purity and improved biomarker detection using precision needle punch enrichment of pathology specimen paraffin blocks: Method validation and implementation in a prospective clinical trial. Journal Of Clinical Oncology 2020, 38: 3622-3622. DOI: 10.1200/jco.2020.38.15_suppl.3622.Peer-Reviewed Original ResearchProspective clinical trialsClinical trialsTumor purityTissue blocksClinical trial enrollmentHomologous recombination deficiency scoresValidation studyTrial enrollmentTrial armsHigh tumor purityPathology specimensShort variantDeficiency scoresParaffin blocksPatient matchingTumor cellsBiomarker resultsStatistical differenceComplex biomarkersPass/fail rateSequencing assaysTrialsGenomic lossScoresGroupFrontline immunotherapy for NSCLC — the tale of the tail
Chiang AC, Herbst RS. Frontline immunotherapy for NSCLC — the tale of the tail. Nature Reviews Clinical Oncology 2020, 17: 73-74. PMID: 31907372, DOI: 10.1038/s41571-019-0317-y.Peer-Reviewed Original Research
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
Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma
Campbell A, Herbst R, Gettinger S, Goldberg S, Kluger H, Chiang A, Lilenbaum R, Schalper K, Sowell R, Kaech S, Decker R. Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma. International Journal Of Radiation Oncology • Biology • Physics 2018, 102: s18-s19. DOI: 10.1016/j.ijrobp.2018.06.134.Peer-Reviewed Original ResearchShould chemotherapy plus immune checkpoint inhibition be the standard front‐line therapy for patients with metastatic non–small cell lung cancer?
Goldberg SB, Herbst RS. Should chemotherapy plus immune checkpoint inhibition be the standard front‐line therapy for patients with metastatic non–small cell lung cancer? Cancer 2018, 124: 4592-4596. PMID: 30383887, PMCID: PMC6443243, DOI: 10.1002/cncr.31681.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerNonsquamous non-small cell lung cancerAdvanced non-small cell lung cancerMetastatic non-small cell lung cancerCell death protein 1 (PD-1) inhibitorsStandard front-line therapyFirst-line settingImmune checkpoint inhibitionFront-line therapyNew treatment optionsProtein 1 inhibitorCheckpoint inhibitionTumor histologyTreatment optionsRecent trialsPatientsCancerChemotherapyTherapyHistologyMajor advancementsTrialsFinal results of a phase I prospective trial evaluating the combination of stereotactic body radiotherapy (SBRT) with concurrent pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma.
Campbell A, Herbst R, Gettinger S, Goldberg S, Kluger H, Chiang A, Lilenbaum R, Schalper K, Sowell R, Kaech S, Decker R. Final results of a phase I prospective trial evaluating the combination of stereotactic body radiotherapy (SBRT) with concurrent pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma. Journal Of Clinical Oncology 2018, 36: 9099-9099. DOI: 10.1200/jco.2018.36.15_suppl.9099.Peer-Reviewed Original Research60 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
2017
Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report
Newman JH, Rich S, Abman SH, Alexander JH, Barnard J, Beck GJ, Benza RL, Bull TM, Chan SY, Chun HJ, Doogan D, Dupuis J, Erzurum SC, Frantz RP, Geraci M, Gillies H, Gladwin M, Gray MP, Hemnes AR, Herbst RS, Hernandez AF, Hill NS, Horn EM, Hunter K, Jing ZC, Johns R, Kaul S, Kawut SM, Lahm T, Leopold JA, Lewis GD, Mathai SC, McLaughlin VV, Michelakis ED, Nathan SD, Nichols W, Page G, Rabinovitch M, Rich J, Rischard F, Rounds S, Shah SJ, Tapson VF, Lowy N, Stockbridge N, Weinmann G, Xiao L. Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report. American Journal Of Respiratory And Critical Care Medicine 2017, 195: 1661-1670. PMID: 28430547, PMCID: PMC5476915, DOI: 10.1164/rccm.201701-0150ws.Peer-Reviewed Original ResearchConceptsPulmonary vascular diseaseClinical trialsPulmonary hypertensionVascular diseaseNational Biological SamplePrecision medicine principlesVascular disease phenotypesNational Precision Medicine InitiativeSmall clinical trialsFuture clinical trialsPrecision medicine approachInnovative statistical designLung diseasePatient populationPatient advocacy organizationsPrecision Medicine InitiativeTherapeutic interventionsClinical investigatorsMedicine approachMedicine principlesMetabolic testsTrialsDiseaseBreakthrough InitiativePharmaceutical industry expertsP2.03b-053 Role of KRAS Mutation Status in NSCLC Patients Treated on SWOG S0819, a Phase III Trial of Chemotherapy with or without Cetuximab Topic: Biomarkers
Mack P, Moon J, Herbst R, Kim E, Semrad T, Redman M, Tsai R, Solis L, Gregg J, Hatcher S, Varella-Garcia M, Hirsch F, Blanke C, Kelly K, Gandara D. P2.03b-053 Role of KRAS Mutation Status in NSCLC Patients Treated on SWOG S0819, a Phase III Trial of Chemotherapy with or without Cetuximab Topic: Biomarkers. Journal Of Thoracic Oncology 2017, 12: s967-s968. DOI: 10.1016/j.jtho.2016.11.1334.Peer-Reviewed Original ResearchP3.02c-042 IMpower110: Phase III Trial Comparing 1L Atezolizumab with Chemotherapy in PD-L1–Selected Chemotherapy-Naive NSCLC Patients Topic: IT
De Marinis F, Jassem J, Spigel D, Lam S, Mocci S, Sandler A, Lopez-Chavez A, Deng Y, Giacconne G, Herbst R. P3.02c-042 IMpower110: Phase III Trial Comparing 1L Atezolizumab with Chemotherapy in PD-L1–Selected Chemotherapy-Naive NSCLC Patients Topic: IT. Journal Of Thoracic Oncology 2017, 12: s1299-s1300. DOI: 10.1016/j.jtho.2016.11.1837.Peer-Reviewed Original Research
2016
PS01.56: IMpower110: Phase III Trial Comparing 1L Atezolizumab with Chemotherapy in PD-L1–Selected Chemotherapy-Naive NSCLC Patients Topic: Medical Oncology
Herbst R, De Marinis F, Jassem J, Lam S, Mocci S, Sandler A, Lopez-Chavez A, Deng Y, Giaccone G, Spigel D. PS01.56: IMpower110: Phase III Trial Comparing 1L Atezolizumab with Chemotherapy in PD-L1–Selected Chemotherapy-Naive NSCLC Patients Topic: Medical Oncology. Journal Of Thoracic Oncology 2016, 11: s304-s305. DOI: 10.1016/j.jtho.2016.09.091.Peer-Reviewed Original ResearchNivolumab and Pembrolizumab for Non–Small Cell Lung Cancer
Morgensztern D, Herbst RS. Nivolumab and Pembrolizumab for Non–Small Cell Lung Cancer. Clinical Cancer Research 2016, 22: 3713-3717. PMID: 27252413, DOI: 10.1158/1078-0432.ccr-15-2998.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungClinical Trials, Phase I as TopicHumansLung NeoplasmsNivolumabPrognosisProgrammed Cell Death 1 ReceptorRandomized Controlled Trials as TopicTreatment OutcomeConceptsCheckpoint inhibitorsClinical trialsAdvanced stage non-small lung cancerDeath-1 checkpoint inhibitorsLarge randomized clinical trialsNon-small lung cancerSecond-line docetaxelSurvivors 3 yearsBest supportive careSubset of patientsRandomized clinical trialsOverall survivalSupportive careCombination therapyLung cancerModest benefitPatientsPhase IImmunotherapyReliable predictorTherapyInhibitorsTrialsTreatmentNivolumabClinician 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 ResearchBiomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC.
Hirsch F, Redman M, Herbst R, Kim E, Semrad T, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold S, Varella-Garcia M, Moon J, Mack P, Blanke C, Kelly K, Gandara D. Biomarker-enriched efficacy of cetuximab-based therapy: Squamous subset analysis from S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC. Journal Of Clinical Oncology 2016, 34: 9090-9090. DOI: 10.1200/jco.2016.34.15_suppl.9090.Peer-Reviewed Original Research
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 Research