2023
SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer
Borghaei H, de Marinis F, Dumoulin D, Reynolds C, Theelen W, Percent I, Calderon V, Johnson M, Madroszyk-Flandin A, Garon E, He K, Planchard D, Reck M, Popat S, Herbst R, Leal T, Shazer R, Yan X, Harrigan R, Peters S, Investigators S, Abdel-Karim I, Abdelsalam M, Addeo A, Aguado C, Alexander P, Alt J, Azzi G, Balaraman R, Biesma B, Blackhall F, Bohnet S, Boleti E, Borghaei H, Bradbury P, Brighenti M, Campbell N, Campbell T, Canon J, Cappuzzo F, Costa E, Cavanna L, Cetnar J, Chella A, Chouaid C, Christoph D, Castán J, Dakhil S, de Castro Carpeño F, de Marinis F, Delmonte A, Demedts I, Demey W, Dits J, del Pilar Diz Taín M, Gómez M, Dorius T, Dumoulin D, Duruisseaux M, Eaton K, González E, Evans D, Faehling M, Farrell N, Feinstein T, Font E, Campelo M, Garon E, López M, Germonpré P, Gersten T, Cao M, Gopaluni S, Greillier L, Grossi F, Guisier F, Gurubhagavatula S, Calderón V, Hakimian D, Hall R, Hao D, Harris R, Hashemi S, He K, Hendriks L, Huang C, Ibrahim E, Jain S, Johnson M, Jones B, Jones M, Vidal Ó, Juergens R, Kaderbhai C, Kastelijn E, Keresztes R, Kio E, Kokowski K, Konduri K, Kulkarni S, Kuon J, Kurkjian C, Labbé C, Lerner R, Lim F, Madroszyk-Flandin A, Marathe O, Martincic D, McClay E, McIntyre K, Mekhail T, Misino A, Molinier O, Morabito A, Morócz É, Müller V, Nagy T, Nguyen A, Nidhiry E, Okazaki I, Ortega-Granados A, Ostoros G, Oubre D, Owen S, Pachipala K, Park D, Patel P, Percent I, Pérol M, Peters S, Piet B, Planchard D, Polychronis A, Aix S, Pons-Tostivint E, Popat S, Pulla M, Quantin X, Quéré G, Rafique N, Ramaekers R, Reck M, Reiman A, Reinmuth N, Reynolds C, Rodríguez-Abreu D, Romano G, Roque T, Salzberg M, Sanborn R, Sandiego S, Schaefer E, Schreeder M, Seetharamu N, Seneviratne L, Shah P, Shunyakov L, Slater D, Parra H, Stigt J, Stilwill J, Su J, Surmont V, Swink A, Szalai Z, Talbot T, Garcia A, Theelen W, Thompson J, Tiseo M, Uprety D, Uyeki J, van der Leest K, Van Ho A, van Putten J, Estévez S, Veatch A, Vergnenègre A, Ward P, Weise A, Weiss M, Whitehurst M, Zai S, Zalcman G, Zuniga R. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. Annals Of Oncology 2023, 35: 66-76. PMID: 37866811, DOI: 10.1016/j.annonc.2023.10.004.Peer-Reviewed Original ResearchClinical benefit rateObjective response rateProgression-free survivalCell lung cancerOverall survivalNonsquamous NSCLCPrimary endpointLung cancerMedian progression-free survivalTreatment-related adverse eventsReceptor tyrosine kinase inhibitorsAdvanced nonsquamous NSCLCCheckpoint inhibitor therapyMedian overall survivalPlatinum-based chemotherapyDuration of responseImmunosuppressive tumor microenvironmentTyrosine kinase inhibitorsImmunostimulatory stateMedian DoRSecondary endpointsMost patientsAdverse eventsInhibitor therapySafety profile
2022
Circulating Tumor DNA Kinetics Predict Progression-Free and Overall Survival in EGFR TKI–Treated Patients with EGFR-Mutant NSCLC (SWOG S1403)
Mack PC, Miao J, Redman MW, Moon J, Goldberg SB, Herbst RS, Melnick MA, Walther Z, Hirsch FR, Politi K, Kelly K, Gandara DR. Circulating Tumor DNA Kinetics Predict Progression-Free and Overall Survival in EGFR TKI–Treated Patients with EGFR-Mutant NSCLC (SWOG S1403). Clinical Cancer Research 2022, 28: 3752-3760. PMID: 35713632, PMCID: PMC9444942, DOI: 10.1158/1078-0432.ccr-22-0741.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalEGFR mutationsNon-small cell lung cancerCycle 3 day 1Median progression-free survivalMedian overall survivalRisk of progressionCell lung cancerPresence of brainEGFR-mutant NSCLCBaseline ctDNAM1b stageProgression-FreeRECIST responseSerial plasmaLiver metastasesDecreased riskEGFR-TKILung cancerComplete clearanceLong-term benefitsClinical trialsTreatment outcomesPlasma clearanceA phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507).
Skoulidis F, Redman M, Suga J, Al Baghdadi T, Villano J, Goldberg S, Villaruz L, Minichiello K, Gandara D, Herbst R, Kelly K. A phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507). Journal Of Clinical Oncology 2022, 40: 9060-9060. DOI: 10.1200/jco.2022.40.16_suppl.9060.Peer-Reviewed Original ResearchObjective response ratePhase II studyCheckpoint inhibitorsII studyStage IVPrior linesGenomic alterationsSingle-arm phase II studyArm phase II studyBest objective response rateMedian progression-free survivalPARP inhibitorsAdequate organ functionCo-primary objectivesDurable disease stabilizationMost grade 3PD-L1 TPSDisease control rateImmune checkpoint inhibitorsMedian overall survivalNon-squamous NSCLCStage IV diseaseProgression-free survivalBest objective responseOptimal therapeutic approach
2021
Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760)
Leighl NB, Redman MW, Rizvi N, Hirsch FR, Mack PC, Schwartz LH, Wade JL, Irvin WJ, Reddy SC, Crawford J, Bradley JD, Stinchcombe TE, Ramalingam SS, Miao J, Minichiello K, Herbst RS, Papadimitrakopoulou VA, Kelly K, Gandara DR. Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760). Journal For ImmunoTherapy Of Cancer 2021, 9: e002973. PMID: 34429332, PMCID: PMC8386207, DOI: 10.1136/jitc-2021-002973.Peer-Reviewed Original ResearchConceptsDisease progressionAnti-programmed death ligand 1 therapyStage IV squamous cell lung cancerPrior anti-PD-1 therapyResponse rateAnti-PD-1 therapyDeath ligand 1 therapyMedian progression-free survivalSquamous cell lung cancerObjective response ratePhase II studyProgression-free survivalCell lung cancerSquamous lung carcinomaDurvalumab 1500Eligible patientsImmunotherapy combinationsPrimary endpointAdverse eventsII studyOverall survivalPartial responseTRIAL REGISTRATIONLung cancerLung carcinomaPhase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G
Owonikoko TK, Redman MW, Byers LA, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam SS, Herbst RS, Papadimitrakopoulou V, Gandara DR. Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G. Clinical Lung Cancer 2021, 22: 187-194.e1. PMID: 33583720, PMCID: PMC8637652, DOI: 10.1016/j.cllc.2021.01.001.Peer-Reviewed Original ResearchConceptsPrimary analysis populationOverall response rateSquamous cell lung cancerDisease control rateCell lung cancerHomologous recombination repair deficiencyLung cancerOverall survivalControl rateMedian progression-free survivalHomologous recombination repair genesSingle-agent talazoparibPhase 2 studyProgression-free survivalRepair deficiencySquamous lung cancerRecombination repair genesMedian durationMedian ageAnalysis populationEligible populationResponse ratePatientsPARP inhibitorsFinding study
2020
SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study)
Borghaei H, Redman MW, Kelly K, Waqar SN, Robert F, Kiefer GJ, Stella PJ, Minichiello K, Gandara DR, Herbst RS, Papadimitrakopoulou VA. SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study). Clinical Lung Cancer 2020, 22: 178-186. PMID: 33358401, PMCID: PMC8686189, DOI: 10.1016/j.cllc.2020.10.015.Peer-Reviewed Original ResearchConceptsDisease control rateMedian overall survivalProgression-free survivalCell lung cancerAdverse eventsOverall survivalControl rateLung cancerRecurrent squamous cell lung cancerPhase II/III trialsDrug-related adverse eventsMedian progression-free survivalPrior platinum-based chemotherapyTreatment-related adverse eventsSquamous cell lung cancerPD-L1 dataPhase II studyPhase II trialPD-L1 antibodiesPlatinum-based chemotherapySingle-agent activityEvaluable patientsII trialPrimary endpointII studyBiomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. The Lancet Oncology 2020, 21: 1589-1601. PMID: 33125909, PMCID: PMC8109255, DOI: 10.1016/s1470-2045(20)30475-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Decision-MakingDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicinePredictive Value of TestsProgression-Free SurvivalTime FactorsYoung AdultConceptsCell lung cancerNational Cancer InstituteTargeted therapy groupLung cancerLung-MAPMaster protocolsDocetaxel groupTherapy groupEastern Cooperative Oncology Group performance statusUnmet needMedian progression-free survivalNational Clinical Trials NetworkMedian overall survivalAdvanced lung cancerProgression-free survivalPlatinum-based chemotherapyClinical Trials NetworkNational InstituteClinical trial componentUS National Cancer InstituteNew screening protocolBristol-Myers SquibbAdditional substudyEligible patientsImmunotherapy combinationsPhase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC
Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L. Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. Journal Of Thoracic Oncology 2020, 16: 289-298. PMID: 33068794, DOI: 10.1016/j.jtho.2020.10.004.Peer-Reviewed Original ResearchConceptsProgression-free survivalTumor proportion scoreMedian progression-free survivalTreatment-related adverse eventsPD-L1 expressionT-cell signatureCD274 gene expressionAdverse eventsPhase 1a/b trialPD-L1 tumor proportion scoreHigh PD-L1 expressionManageable safety profileMedian overall survivalObjective response ratePD-L1 positivityFirst-line therapyOverall survival ratePD-L1 immunohistochemistryCohort EPembrolizumab treatmentPFS ratesExpansion cohortClinical responseOverall survivalEfficacy signals
2019
SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Edelman MJ, Redman MW, Albain KS, McGary EC, Rafique NM, Petro D, Waqar SN, Minichiello K, Miao J, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1853-1859. PMID: 31302234, PMCID: PMC6764876, DOI: 10.1016/j.jtho.2019.06.027.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCell Cycle ProteinsFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPiperazinesPyridinesSalvage TherapySurvival RateConceptsSquamous NSCLCEligible patientsStage IV squamous cell lung cancerPhase II/III trialsCell cycle gene alterationsCyclin D3 gene amplificationMedian progression-free survivalPrior platinum-based chemotherapySquamous cell lung cancerSingle-arm phase II trialMedian overall survivalPhase II studyPrimary end pointPhase II trialProgression-free survivalPlatinum-based chemotherapyCell lung cancerNormal organ functionCyclin-dependent kinase 4Cyclin-dependent kinase 4 geneKinase 4 geneStable diseaseII trialII studyIII trialsSWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Aggarwal C, Redman MW, Lara PN, Borghaei H, Hoffman P, Bradley JD, Newman AJ, Feldman MJ, Minichiello K, Miao J, Mack PC, Papadimitrakopoulou VA, Herbst RS, Kelly K, Gandara DR. SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1847-1852. PMID: 31195180, PMCID: PMC6901020, DOI: 10.1016/j.jtho.2019.05.041.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBenzamidesBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPiperazinesPyrazolesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 3Salvage TherapySurvival RateConceptsProgression-free survivalFGFR3 S249CFGFR alterationsOverall survivalPartial responseFGFR1 amplificationLung-MAPGrade 3 adverse eventsMedian progression-free survivalPlatinum-based systemic therapySolid Tumors version 1.1Squamous cell lung cancerMedian age 66 yearsFibroblast growth factor receptor inhibitorGrowth factor receptor inhibitorsFirst phase II trialGrade 4 sepsisResponse-evaluable patientsSquamous cell NSCLCUnconfirmed partial responsePhase II studyAcceptable safety profilePhase II trialResponse Evaluation CriteriaAge 66 yearsSWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
Langer CJ, Redman MW, Wade JL, Aggarwal C, Bradley JD, Crawford J, Stella PJ, Knapp MH, Miao J, Minichiello K, Herbst RS, Kelly K, Gandara DR, Papadimitrakopoulou VA. SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study). Journal Of Thoracic Oncology 2019, 14: 1839-1846. PMID: 31158500, PMCID: PMC7017958, DOI: 10.1016/j.jtho.2019.05.029.Peer-Reviewed Original ResearchConceptsPrimary analysis populationProgression-free survivalPrimary endpointOverall survivalStage IV squamous cell lung cancerGrade 3 adverse eventsMedian progression-free survivalSolid Tumors version 1.1Squamous cell lung cancerTreatment-related deathsPhase II studyResponse Evaluation CriteriaSubset of patientsCell lung cancerDuration of responsePlatinum-based therapyInterim futility analysisPI3K inhibitorsEligible patientsEvaluable populationSquamous NSCLCSecondary endpointsAdverse eventsII studyMedian age
2018
Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF)
Arkenau H, Martin‐Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF). The Oncologist 2018, 23: 1407-e136. PMID: 29853658, PMCID: PMC6292555, DOI: 10.1634/theoncologist.2018-0044.Peer-Reviewed Original ResearchConceptsMetastatic biliary tract cancerTreatment-related adverse eventsBiliary tract cancerObjective response rateProgression-free survivalOverall survivalTract cancerCommon grade 3 treatment-related adverse eventsGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsDay 1Response rateAdvanced biliary tract cancerMedian progression-free survivalBiomarker-unselected patientsEfficacy of ramucirumabInfrequent grade 3Limited clinical activityPD-1 antagonistsTreatment-related deathsUnexpected safety findingsVEGFR-2 antagonistGrowth factor receptor 2Phase I trialExtrahepatic bile ductSafety and antitumor activity of ramucirumab plus pembrolizumab in treatment naïve advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Preliminary results from a multi-disease phase I study (JVDF).
Chau I, Penel N, Arkenau H, Santana-Davila R, Calvo E, Soriano A, Mi G, Jin J, Ferry D, Herbst R, Fuchs C. Safety and antitumor activity of ramucirumab plus pembrolizumab in treatment naïve advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Preliminary results from a multi-disease phase I study (JVDF). Journal Of Clinical Oncology 2018, 36: 101-101. DOI: 10.1200/jco.2018.36.4_suppl.101.Peer-Reviewed Original ResearchTreatment-related adverse eventsGEJ adenocarcinomaMedian durationPD-L1Study treatmentPreliminary efficacyGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsDay 1Grade treatment-related adverse eventsPhase 1a/b trialMedian progression-free survivalCell death 1 proteinAntitumor activityDisease control rateECOG PS 0Median overall survivalMedian treatment durationPD-L1 statusProgression-free survivalGrowth factor receptor 2Gastroesophageal junction adenocarcinomaDeath 1 proteinBaseline tumor tissueEndothelial growth factor receptor 2
2017
Phase II study of the FGFR inhibitor AZD4547 in previously treated patients with FGF pathway-activated stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400D.
Aggarwal C, Redman M, Lara P, Borghaei H, Hoffman P, Bradley J, Griffin K, Miao J, Mack P, Papadimitrakopoulou V, Herbst R, Kelly K, Gandara D. Phase II study of the FGFR inhibitor AZD4547 in previously treated patients with FGF pathway-activated stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400D. Journal Of Clinical Oncology 2017, 35: 9055-9055. DOI: 10.1200/jco.2017.35.15_suppl.9055.Peer-Reviewed Original ResearchOverall response rateProgression-free survivalFGFR inhibitor AZD4547Eligible ptsFGFR3 S249CStage IV squamous cell lung cancerAdequate end-organ functionMedian progression-free survivalSquamous cell lung cancerFirst phase II trialGrade 3 AEsGrade 4 sepsisGrade 5 AEsPhase II studyAcceptable safety profileEmergence of immunotherapyEnd-organ functionPhase II trialCell lung cancerDuration of responseEvaluable ptsMeasurable diseaseUnconfirmed PRII trialPrimary endpoint
2016
The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer
Papadimitrakopoulou V, Lee JJ, Wistuba II, Tsao AS, Fossella FV, Kalhor N, Gupta S, Byers LA, Izzo JG, Gettinger SN, Goldberg SB, Tang X, Miller VA, Skoulidis F, Gibbons DL, Shen L, Wei C, Diao L, Peng SA, Wang J, Tam AL, Coombes KR, Koo JS, Mauro DJ, Rubin EH, Heymach JV, Hong WK, Herbst RS. The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 3638-3647. PMID: 27480147, PMCID: PMC5065110, DOI: 10.1200/jco.2015.66.0084.Peer-Reviewed Original ResearchDisease control rateKRAS wild-type patientsMedian overall survivalProgression-free survivalWild-type patientsArm 1Overall survivalKRAS statusArm 3Lung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerBiomarker-driven treatment strategiesLung Cancer Elimination (BATTLE) trialMedian progression-free survivalImproved progression-free survivalBiomarker-Integrated ApproachesReal-time biopsyPrimary end pointCell lung cancerPrior therapyUmbrella studyAdvanced NSCLCControl rateMesenchymal tumors
2015
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial
Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet 2015, 387: 1540-1550. PMID: 26712084, DOI: 10.1016/s0140-6736(15)01281-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelDrug Administration ScheduleFemaleGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyPatient SelectionTaxoidsTreatment OutcomeConceptsCell lung cancerProgression-free survivalPD-L1 expressionOverall survivalLung cancerPD-L1Tumor cellsMedian progression-free survivalTreatment-related adverse eventsEfficacy of pembrolizumabMedian overall survivalProlongs overall survivalNew treatment optionsAcademic medical centerPrimary endpointAdverse eventsProgressive diseasePatient populationTotal populationTreatment optionsPembrolizumabGrade 3Medical CenterEffective treatmentInteractive voice response system
2013
Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial
Blumenschein GR, Saintigny P, Liu S, Kim ES, Tsao AS, Herbst RS, Alden C, Lee JJ, Tang X, Stewart DJ, Kies MS, Fossella FV, Tran HT, Mao L, Hicks ME, Erasmus J, Gupta S, Girard L, Peyton M, Diao L, Wang J, Davis SE, Minna JD, Wistuba I, Hong WK, Heymach JV, Lippman SM. Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial. Clinical Cancer Research 2013, 19: 6967-6975. PMID: 24166906, PMCID: PMC3905243, DOI: 10.1158/1078-0432.ccr-12-1818.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerDisease control rateProgression-free survivalWild-type EGFROverall survivalClinical benefitEGFR gene copy number gainMedian progression-free survivalWild-type EGFR tumorsImproved progression-free survivalComprehensive biomarker analysisCell lung cancerGene copy number gainEGFR gene copy numberNSCLC cell linesGrowth factor-1Patient tumor biopsiesFibroblast growth factor 1Unacceptable toxicityEGFR tumorsClinical efficacyFuture trialsControl rateLung cancerEGFR mutationsPhase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non–Small-Cell Lung Cancer: SWOG S0536
Kim ES, Moon J, Herbst RS, Redman MW, Dakhil SR, Velasco MR, Hirsch FR, Mack PC, Kelly K, Heymach JV, Gandara DR. Phase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non–Small-Cell Lung Cancer: SWOG S0536. Journal Of Thoracic Oncology 2013, 8: 1519-1528. PMID: 24189513, PMCID: PMC4072123, DOI: 10.1097/jto.0000000000000009.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCetuximabFeasibility StudiesFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelPrognosisSurvival RateConceptsPhase II trialProgression-free survivalII trialPrimary endpointOverall survivalLung cancerAdvanced nonsquamous non-small cell lung cancerNonsquamous non-small cell lung cancerResponse rateNon-small cell lung cancerMedian progression-free survivalOverall disease control rateCycles of carboplatinPlatinum-based doubletsTreatment-related deathsChemotherapy-naive patientsDisease control rateMedian overall survivalCombination of carboplatinCell lung cancerHigher hemorrhageMaintenance cetuximabStable diseaseAdvanced NSCLCNonsquamous NSCLC
2012
Clinical Outcomes and Biomarker Profiles of Elderly Pretreated NSCLC Patients from the BATTLE Trial
Tsao AS, Liu S, Lee JJ, Alden C, Blumenschein G, Herbst R, Davis SE, Kim E, Lippman S, Stewart D, Tang XM, Wistuba I, Hong WK. Clinical Outcomes and Biomarker Profiles of Elderly Pretreated NSCLC Patients from the BATTLE Trial. Journal Of Thoracic Oncology 2012, 7: 1645-1652. PMID: 23059780, PMCID: PMC5161038, DOI: 10.1097/jto.0b013e31826910ff.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBexaroteneBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDrug Resistance, NeoplasmErlotinib HydrochlorideFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingNiacinamidePhenylurea CompoundsPiperidinesPrognosisQuinazolinesRetrospective StudiesSalvage TherapySorafenibSurvival RateTetrahydronaphthalenesConceptsProgression-free survivalDisease control rateNSCLC patientsOverall survivalElderly menGrade 3Older womenOlder menBetter median progression-free survivalHigher disease control rateLung Cancer Elimination (BATTLE) trialMedian progression-free survivalAge groupsBetter progression-free survivalCell lung cancer patientsBiomarker-Integrated ApproachesBiopsy-related pneumothoraxElderly NSCLC patientsMore grade 3Treatment-related deathsTumor tissue biomarkersRetrospective subgroup analysisSubset of patientsHigher overall survivalLung cancer patients
2011
An Open-Label, Multicenter, Three-Stage, Phase II Study of S-1 in Combination with Cisplatin as First-Line Therapy for Patients with Advanced Non-small Cell Lung Cancer
Sandler A, Graham C, Baggstrom M, Herbst R, Zergebel C, Saito K, Jones D. An Open-Label, Multicenter, Three-Stage, Phase II Study of S-1 in Combination with Cisplatin as First-Line Therapy for Patients with Advanced Non-small Cell Lung Cancer. Journal Of Thoracic Oncology 2011, 6: 1400-1406. PMID: 21673602, DOI: 10.1097/jto.0b013e31820d7805.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinDrug CombinationsFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingOxonic AcidSurvival RateTegafurTreatment OutcomeConceptsNon-small cell lung cancerCell lung cancerLung cancerUnresectable non-small cell lung cancerAdvanced non-small cell lung cancerDay 1Response rateBest overall response rateMedian progression-free survivalCisplatin-based doubletsProtocol-specified criteriaDisease control rateObjective response ratePrimary end pointPhase II studyProgression-free survivalDeep vein thrombosisOverall response rateCisplatin regimenGastrointestinal toxicityOpen labelOral agentsAdverse eventsII studyLine therapy