2023
LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC)
Borghaei H, Johnson M, Garon E, He K, Planchard D, Reck M, Popat S, Herbst R, Leal T, Dumoulin D, de Marinis F, Reynolds C, Theelen W, Percent I, Calderon V, Flandin A, Shazer R, Yan X, Harrigan R, Peters S. LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Annals Of Oncology 2023, 34: s1308. DOI: 10.1016/j.annonc.2023.10.064.Peer-Reviewed Original ResearchNovel 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
2020
Lung-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 partsFoundationOneNSCLCS1400Frontline 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
OA04.01 A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Cell Lung Cancer
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. OA04.01 A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Cell Lung Cancer. Journal Of Thoracic Oncology 2019, 14: s214. DOI: 10.1016/j.jtho.2019.08.423.Peer-Reviewed Original ResearchA 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
2016
Nivolumab 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 predictorTherapyInhibitorsTrialsTreatmentNivolumab