2019
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).
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
2013
Retrospective evaluation of RET biomarker status and outcome to vandetanib in four phase III randomized NSCLC trials.
Platt A, Elvin P, Morten J, Ji Q, Donald E, Womack C, Su X, Zheng L, Gladwin A, Vasselli J, Lee J, De Boer R, Herbst R. Retrospective evaluation of RET biomarker status and outcome to vandetanib in four phase III randomized NSCLC trials. Journal Of Clinical Oncology 2013, 31: 8045-8045. DOI: 10.1200/jco.2013.31.15_suppl.8045.Peer-Reviewed Original ResearchRET fusionsNSCLC trialsTumor samplesRET fusion genesFusion-positive patientsGene copy number gainRET protein expressionRECIST responseRadiologic evidenceEvaluable dataTumor shrinkageNSCLC tumorsBiomarker statusIHC analysisCopy number gainsRET amplificationRetrospective evaluationPatientsPotential associationVandetanibRET expressionPrevalenceProtein expressionPhase IIIBiomarkers
2011
Meta-analysis of the predictive and prognostic value of erlotinib-related biomarkers in phase III, placebo-controlled trials in non-small cell lung cancer (NSCLC): Recommendations of the BioLOGUE advisors.
Soulieres D, Wolf J, Shepherd F, Cappuzzo F, Bunn P, Herbst R, Hirsch F, Kerr K, Mitsudomi T, Tsao M, Yang C, Richardson F, Klughammer B, Wacker B, Sternberg D, Davies A. Meta-analysis of the predictive and prognostic value of erlotinib-related biomarkers in phase III, placebo-controlled trials in non-small cell lung cancer (NSCLC): Recommendations of the BioLOGUE advisors. Journal Of Clinical Oncology 2011, 29: 7533-7533. DOI: 10.1200/jco.2011.29.15_suppl.7533.Peer-Reviewed Original Research
2004
Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial of paclitaxel (Pac) and carboplatin (C) combined with erlotinib (E) or placebo in patients with advanced non-small cell lung cancer(NSCLC)
Tran H, Zinner R, Blumenschein G, Oh Y, Papadimitrakopoulou V, Kim E, Lu C, Malik M, Lum B, Herbst R. Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial of paclitaxel (Pac) and carboplatin (C) combined with erlotinib (E) or placebo in patients with advanced non-small cell lung cancer(NSCLC). Journal Of Clinical Oncology 2004, 22: 2050-2050. DOI: 10.1200/jco.2004.22.14_suppl.2050.Peer-Reviewed Original ResearchPharmacokinetic study of the phase III, randomized, double-blind, multicenter trial of paclitaxel (Pac) and carboplatin (C) combined with erlotinib (E) or placebo in patients with advanced non-small cell lung cancer(NSCLC)
Tran H, Zinner R, Blumenschein G, Oh Y, Papadimitrakopoulou V, Kim E, Lu C, Malik M, Lum B, Herbst R. Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial of paclitaxel (Pac) and carboplatin (C) combined with erlotinib (E) or placebo in patients with advanced non-small cell lung cancer(NSCLC). Journal Of Clinical Oncology 2004, 22: 2050-2050. DOI: 10.1200/jco.2004.22.90140.2050.Peer-Reviewed Original Research