2024
SWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.
Reckamp K, Redman M, Dragnev K, Iams W, Henick B, Miao J, LeBlanc M, Carrizosa D, Herbst R, Blanke C, Gray J. SWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. Journal Of Clinical Oncology 2024, 42: tps8657-tps8657. DOI: 10.1200/jco.2024.42.16_suppl.tps8657.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerStandard of careCell lung cancerPD-(L)1Overall survivalAdverse eventsRecurrent non-small cell lung cancerLung cancerTreatment-related adverse eventsRandomized phase II trialStandard of care treatmentPlatinum-based therapyTreated with immunotherapyPhase II trialLog-rank testCompare OSInhibitor therapyII trialCombination therapyStatistically significant improvementTumor resistanceSafety profileTherapeutic optionsRandomized study
2022
Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non–Small-Cell Lung Cancer Previously Treated With Immunotherapy—Lung-MAP S1800A
Reckamp KL, Redman MW, Dragnev KH, Minichiello K, Villaruz LC, Faller B, Al Baghdadi T, Hines S, Everhart L, Highleyman L, Papadimitrakopoulou V, Neal J, Waqar SN, Patel JD, Gray JE, Gandara DR, Kelly K, Herbst RS. Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non–Small-Cell Lung Cancer Previously Treated With Immunotherapy—Lung-MAP S1800A. Journal Of Clinical Oncology 2022, 40: 2295-2306. PMID: 35658002, PMCID: PMC9287284, DOI: 10.1200/jco.22.00912.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitionInvestigator-assessed progression-free survivalProgression-free survivalOverall survivalVascular endothelial growth factorLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerPhase II Randomized StudyTreatment-related adverse eventsRandomized phase II trialSecondary end pointsPhase II trialPlatinum-based chemotherapyCell lung cancerDuration of responseLog-rank testMajor unmet needEndothelial growth factorMultiple tumor typesAdvanced NSCLCEligible patientsOS benefitII trialObjective responseOverall survival from a phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non–small cell lung cancer previously treated with immunotherapy: Lung-MAP nonmatched substudy S1800A.
Reckamp K, Redman M, Dragnev K, Villaruz L, Faller B, Al Baghdadi T, Hines S, Qian L, Minichiello K, Gandara D, Kelly K, Herbst R. Overall survival from a phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non–small cell lung cancer previously treated with immunotherapy: Lung-MAP nonmatched substudy S1800A. Journal Of Clinical Oncology 2022, 40: 9004-9004. DOI: 10.1200/jco.2022.40.16_suppl.9004.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalOverall survivalCell lung cancerProgressive diseaseLung cancerLung-MAPImmune checkpoint inhibitor therapyPlatinum-based doublet therapyRandomized phase II trialVEGF receptor inhibitionCheckpoint inhibitor therapyImproved overall survivalPD-L1 expressionPhase II trialPotential survival benefitDuration of responseLog-rank testStandard of careTumor mutational burdenMajor unmet needAnalysis of survivalMultiple tumor typesCare arm
2010
Phase II Selection Design Trial of Concurrent Chemotherapy and Cetuximab Versus Chemotherapy Followed by Cetuximab in Advanced-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Study S0342
Herbst RS, Kelly K, Chansky K, Mack PC, Franklin WA, Hirsch FR, Atkins JN, Dakhil SR, Albain KS, Kim ES, Redman M, Crowley JJ, Gandara DR. Phase II Selection Design Trial of Concurrent Chemotherapy and Cetuximab Versus Chemotherapy Followed by Cetuximab in Advanced-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Study S0342. Journal Of Clinical Oncology 2010, 28: 4747-4754. PMID: 20921467, PMCID: PMC3020704, DOI: 10.1200/jco.2009.27.9356.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Non-Small-Cell LungCetuximabDisease-Free SurvivalDrug Administration ScheduleErbB ReceptorsErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationNeoplasm StagingPaclitaxelPatient SelectionProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsResearch DesignSouthwestern United StatesTreatment OutcomeConceptsCell lung cancerConcurrent chemotherapyLung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsProgression-free survival timeRandomized phase II trialReceptor tyrosine kinase inhibitorsMedian overall survivalPaclitaxel/carboplatinTreatment-naive patientsGrade 3 rashPhase II trialAdvanced-stage NSCLCPhase III evaluationTyrosine kinase inhibitorsEnhanced antitumor activityConcurrent regimenMaintenance cetuximabMedian followVersus ChemotherapyChemotherapy regimenII trialSequential therapyConcurrent therapy
2009
Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514
Bahleda R, Soria J, Harbison C, Park J, Felip E, Hanna N, Laurie S, Armand J, Shepherd F, Herbst R. Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514. Journal Of Clinical Oncology 2009, 27: 8098-8098. DOI: 10.1200/jco.2009.27.15_suppl.8098.Peer-Reviewed Original ResearchBMS-690514Skin rashPD biomarkersSkin biopsiesKRAS mutationsPhase I/II studyNon-small cell lung cancer patientsReversible acute renal insufficiencyRandomized phase II trialCell lung cancer patientsEGFR T790M mutationAdequate organ functionOral selective inhibitorDisease control rateAcute renal insufficiencyPhase I portionPhase II trialLung cancer patientsT790M mutationSubsequent surgical removalAnti-tumor activityEGFR copy numberEGFR T790MECOG PSEligible patients
2008
Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC
Herbst RS, Sandler A. Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC. The Oncologist 2008, 13: 1166-1176. PMID: 18997180, DOI: 10.1634/theoncologist.2008-0108.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerF. Hoffmann-La Roche LtdEpidermal growth factor receptorAdvanced non-small cell lung cancerTumor growthRandomized phase II trialRecombinant humanized monoclonal antibodyHuman epidermal growth factor receptorCombination of bevacizumabPhase II trialSelective tyrosine kinase inhibitorAdditional clinical benefitSecond-line alternativeCell lung cancerPotential predictive markerHumanized monoclonal antibodyVascular endothelial growth factorTyrosine kinase inhibitorsSouth San FranciscoEndothelial growth factorGrowth factor receptorAdvanced diseaseErlotinib monotherapyII trialProspective trial
2007
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Chemotherapy or Erlotinib Compared With Chemotherapy Alone for Treatment of Recurrent or Refractory Non–Small-Cell Lung Cancer
Herbst RS, O'Neill VJ, Fehrenbacher L, Belani CP, Bonomi PD, Hart L, Melnyk O, Ramies D, Lin M, Sandler A. Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Chemotherapy or Erlotinib Compared With Chemotherapy Alone for Treatment of Recurrent or Refractory Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2007, 25: 4743-4750. PMID: 17909199, DOI: 10.1200/jco.2007.12.3026.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdenocarcinoma, Bronchiolo-AlveolarAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Large CellCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelErlotinib HydrochlorideFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPemetrexedQuinazolinesSurvival RateTaxoidsTreatment OutcomeConceptsProgression-free survivalAdverse eventsLung cancerHumanized anti-vascular endothelial growth factor monoclonal antibodyRefractory non-small cell lung cancerAnti-vascular endothelial growth factor monoclonal antibodyEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerSingle-arm phase IRandomized phase II trialOne-year survival rateReceptor tyrosine kinase inhibitorsFatal pulmonary hemorrhagePlatinum-based regimenSafety of bevacizumabStudies of bevacizumabUnexpected safety signalsPhase II studySecond-line settingPhase II trialTreatment of recurrentCell lung cancerFactor monoclonal antibodyFavorable safety profileRandomized phase II study of vandetanib (VAN) alone or in combination with carboplatin and paclitaxel (CP) as first-line treatment for advanced non-small cell lung cancer (NSCLC)
Heymach J, Paz-Ares L, De Braud F, Sebastian M, Stewart D, Eberhardt W, Herbst R, Krebs A, Langmuir P, Johnson B. Randomized phase II study of vandetanib (VAN) alone or in combination with carboplatin and paclitaxel (CP) as first-line treatment for advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2007, 25: 7544-7544. DOI: 10.1200/jco.2007.25.18_suppl.7544.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalAdvanced non-small cell lung cancerRandomized phase II trialPhase II trialOverall survivalII trialMedian progression-free survivalRandomized phase II studyCTC grade 2Daily oral agentObjective response ratePlasma angiogenic factorsPhase II studyFirst-line treatmentCell lung cancerExploratory subgroup analysisFemale ptsCNS metastasesEligible patientsMonotherapy armSecondary endpointsSquamous histologyII studyOral agents
2006
Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways
Sandler A, Herbst R. Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways. Clinical Cancer Research 2006, 12: 4421s-4425s. PMID: 16857821, DOI: 10.1158/1078-0432.ccr-06-0796.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDrug SynergismEpidermal Growth FactorErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleQuinazolinesVascular Endothelial Growth Factor AConceptsNon-small cell lung cancerPhase II doseStage IIIB/IV non-small cell lung cancerAdvanced non-small cell lung cancerPhase I/II studyEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsRandomized phase II trialVascular endothelial growth factor (VEGF) pathwaySelective epidermal growth factor receptor tyrosine kinase inhibitorEndothelial growth factor pathwayReceptor tyrosine kinase inhibitorsGrowth factorCommon adverse eventsMedian overall survivalPhase II trialPhase III trialsProgression-free survivalSafety of erlotinibCell lung cancerHumanized monoclonal antibodyVascular endothelial growth factorTyrosine kinase inhibitorsEndothelial growth factorGrowth factor pathwaysConcurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): A randomized phase II selectional trial SWOG 0342
Kelly K, Herbst R, Crowley J, McCoy J, Atkins J, Lara P, Dakhil S, Albain K, Kim E, Gandara D. Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): A randomized phase II selectional trial SWOG 0342. Journal Of Clinical Oncology 2006, 24: 7015-7015. DOI: 10.1200/jco.2006.24.18_suppl.7015.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase II trialII trialLarge randomized phase II trialRandomized phase II trialSmall-molecule EGFR tyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsAdequate organ functionPhase III settingPhase III trialsYears of therapyCell lung cancerRandomized clinical trialsMolecular correlative studiesTyrosine kinase inhibitorsAnti-tumor activityTrue hazard ratioConcurrent chemotherapyConcurrent regimenEligible ptsPrimary endpointStage IIIBUntreated patientsHazard ratioA phase II, multicenter, randomized clinical trial to evaluate the efficacy and safety of bevacizumab in combination with either chemotherapy (docetaxel or pemetrexed) or erlotinib hydrochloride compared with chemotherapy alone for treatment of recurrent or refractory non-small cell lung cancer
Fehrenbacher L, O’Neill V, Belani C, Bonomi P, Hart L, Melnyk O, Sandler A, Ramies D, Herbst R. A phase II, multicenter, randomized clinical trial to evaluate the efficacy and safety of bevacizumab in combination with either chemotherapy (docetaxel or pemetrexed) or erlotinib hydrochloride compared with chemotherapy alone for treatment of recurrent or refractory non-small cell lung cancer. Journal Of Clinical Oncology 2006, 24: 7062-7062. DOI: 10.1200/jco.2006.24.18_suppl.7062.Peer-Reviewed Original ResearchDisease progressionArm 1Single-arm phase I/II studyRefractory non-small cell lung cancerPhase I/II studyNon-small cell lung cancerRandomized phase II trialEGFR tyrosine kinase inhibitorsAnti-VEGF mAbsPlatinum-based regimenSafety of bevacizumabCombination of bevacizumabFirst-line settingNon-squamous NSCLCAdvanced stage diseaseAvailable EGFR tyrosine kinase inhibitorsPhase II trialProgression-free survivalTreatment of recurrentCell lung cancerClinical disease progressionFavorable safety profileTreatment of NSCLCTyrosine kinase inhibitorsAdenocarcinoma/
2002
Non-small cell lung cancer clinical trials with trastuzumab: their foundation and preliminary results
Zinner RG, Kim J, Herbst RS. Non-small cell lung cancer clinical trials with trastuzumab: their foundation and preliminary results. Lung Cancer 2002, 37: 17-27. PMID: 12057863, DOI: 10.1016/s0169-5002(02)00035-1.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerHER2 overexpressionClinical trialsHER2-overexpressing metastatic breast cancerAntibody-dependent cell-mediated cytotoxicityMetastatic breast cancer trialsRandomized phase II trialRecombinant humanized monoclonal antibodyActivity of trastuzumabNSCLC clinical specimensPhase II studyPhase II trialEfficacy of trastuzumabMetastatic breast cancerBreast cancer trialsCell lung cancerCell-mediated cytotoxicityPoor clinical outcomeTreatment of patientsLung cancer clinical trialsHumanized monoclonal antibodyCombination of chemotherapyOverexpression of HER2Cancer clinical trialsDownregulation of HER2