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 profileQuality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I
Unger J, Qian L, Redman M, Tavernier S, Minasian L, Sigal E, Papadimitrakopoulou V, Leblanc M, Cleeland C, Dzingle S, Summers T, Chao H, Madhusudhana S, Villaruz L, Crawford J, Gray J, Kelly K, Gandara D, Bazhenova L, Herbst R, Gettinger S, Moinpour C. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. Journal Of The National Cancer Institute 2023, 115: 437-446. PMID: 36625510, PMCID: PMC10086628, DOI: 10.1093/jnci/djad003.Peer-Reviewed Original ResearchConceptsQuality of lifeComposite risk modelAppetite lossSeverity scoreWeek 13Advanced squamous cell lung cancerWeek 7Baseline patient-reported outcomesRandomized phase III trialSquamous cell lung cancerPhase III trialsRisk of progressionShortness of breathCell lung cancerPatient-reported outcomesRisk of deathMultivariable linear regressionEffect of treatmentEvaluable patientsPrimary endpointIII trialsOverall survivalMedian ageAdvanced cancerPrognostic relevance
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 carcinoma
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 studyRamucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial
Chau I, Penel N, Soriano AO, Arkenau HT, Cultrera J, Santana-Davila R, Calvo E, Le Tourneau C, Zender L, Bendell JC, Mi G, Gao L, McNeely SC, Oliveira JM, Ferry D, Herbst RS, Fuchs CS. Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial. Cancers 2020, 12: 2985. PMID: 33076423, PMCID: PMC7602637, DOI: 10.3390/cancers12102985.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalOverall survivalPD-L1GEJ cancerGrade 3 treatment-related adverse eventsTreatment-related adverse eventsAlanine/aspartate aminotransferaseDurable clinical activityFirst-line patientsPrior systemic chemotherapyAntitumor activityDuration of responseSpectrum of patientsStudy design limitationsCheckpoint inhibitorsMetastatic settingPrimary endpointSecondary endpointsSystemic chemotherapyTreatment-naïveAdvanced gastricAdverse eventsAdvanced cancerPositive tumorsA Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)
Waqar SN, Redman MW, Arnold SM, Hirsch FR, Mack PC, Schwartz LH, Gandara DR, Stinchcombe TE, Leighl NB, Ramalingam SS, Tanna SH, Raddin RS, Minichiello K, Bradley JD, Kelly K, Herbst RS, Papadimitrakopoulou VA. A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Clinical Lung Cancer 2020, 22: 170-177. PMID: 33221175, PMCID: PMC8044254, DOI: 10.1016/j.cllc.2020.09.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPneumoniaProgression-Free SurvivalProto-Oncogene Proteins c-metSurvival RateTreatment OutcomeConceptsSquamous cell carcinomaProgression-free survivalTelisotuzumab vedotinCohort 1Recurrent squamous cell lung cancerSquamous cell lung cancerGrade 5 eventsMET-positive tumorsSolid Tumors v1.1Disease control ratePhase II studyResponse Evaluation CriteriaCell lung cancerDuration of responseLack of efficacyEvaluable patientsStable diseasePrimary endpointSecondary endpointsUnacceptable toxicityII studyOverall survivalCell carcinomaControl rateLung cancerPatient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC.
de Marinis F, Giaccone G, Herbst R, Oprean C, Szczesna A, Boukovinas I, Bonomi L, Kim Y, Summers Y, Kurata T, Komatsubara K, Chen M, Deng Y, Kuriki H, Mocci S, Phan S, Jassem J, Spigel D. Patient-reported outcomes (PROs) in the randomized, phase III IMpower110 study of atezolizumab (atezo) vs chemotherapy in 1L metastatic NSCLC. Journal Of Clinical Oncology 2020, 38: 9594-9594. DOI: 10.1200/jco.2020.38.15_suppl.9594.Peer-Reviewed Original ResearchPatient-reported outcomesGlobal health statusLung cancer-related symptomsLung cancer symptomsCancer-related symptomsChest painWk 48Metastatic NSCLCSymptom burdenPhysical functionCancer symptomsLife Questionnaire Core 30Carboplatin AUC 6Overall clinical benefitStart of treatmentCompletion ratesAUC 5AUC 6Gemcitabine 1250Meaningful worseningNausea/OS benefitQLQ-LC13Primary endpointPD-L1O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC
Herbst R, De Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Font E, Andric Z, Geater S, Ozguroglu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Spigel D. O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC. Journal For ImmunoTherapy Of Cancer 2020, 8: a1. DOI: 10.1136/lba2019.1.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPrimary endpointArm APD-L1Interim overall survival analysisTumor PD-L1 statusPD-L1/PDCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsFirst-line treatmentPD-L1 statusPhase III studyPlatinum-based chemotherapyWT populationOverall survival analysisDeclaration of HelsinkiAttractive treatment choiceAtezolizumab monotherapyAUC 5AUC 6CPI monotherapyECOG PS
2019
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)
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 agePhase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753).
Waqar S, Redman M, Arnold S, Hirsch F, Mack P, Schwartz L, Gandara D, Stinchcombe T, Leighl N, Ramalingam S, Tanna S, Raddin R, Minichiello K, Kelly K, Bradley J, Herbst R, Papadimitrakopoulou V. Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753). Journal Of Clinical Oncology 2019, 37: 9075-9075. DOI: 10.1200/jco.2019.37.15_suppl.9075.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCohort 1Interim analysisLung squamous cell cancerAdequate organ functionDisease control rateMedian overall survivalPhase II studySquamous cell cancerDuration of responseEvaluable patientsG3 eventsImmunotherapy exposureRECIST 1.1Stable diseasePrimary endpointSecondary endpointsUnacceptable toxicityAdverse eventsII studyHepatic involvementCell cancerPositive tumorsControl rateRandomized, double-blind, phase 3 trial of first-line pembrolizumab + platinum doublet chemotherapy (chemo) ± lenvatinib in patients (pts) with metastatic nonsquamous non–small-cell lung cancer (NSCLC): LEAP-006.
Hui R, Nishio M, Reck M, Rodriguez-Abreu D, Fouad T, Flaim D, Yin L, Dang T, Herbst R. Randomized, double-blind, phase 3 trial of first-line pembrolizumab + platinum doublet chemotherapy (chemo) ± lenvatinib in patients (pts) with metastatic nonsquamous non–small-cell lung cancer (NSCLC): LEAP-006. Journal Of Clinical Oncology 2019, 37: tps9118-tps9118. DOI: 10.1200/jco.2019.37.15_suppl.tps9118.Peer-Reviewed Original ResearchPrimary endpointPD-L1 tumor proportion scoreFirst-line lenvatinibMetastatic nonsquamous NSCLCNCI CTCAE v4.0Platinum-doublet chemotherapyFirst-line pembrolizumabPhase 3 trialTumor proportion scoreDose-limiting toxicityKaplan-Meier methodCell lung cancerLog-rank testQuality of lifeDoublet chemotherapyECOG PSMaintenance pembrolizumabAdvanced NSCLCNonsquamous NSCLCSecondary endpointsStudy withdrawalCTCAE v4.0Carboplatin AUCNew cancer therapiesLung cancerA 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
2017
A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B.
Wade J, Langer C, Redman M, Aggarwal C, Bradley J, Crawford J, Miao J, Griffin K, Herbst R, Kelly K, Gandara D, Papadimitrakopoulou V. A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B. Journal Of Clinical Oncology 2017, 35: 9054-9054. DOI: 10.1200/jco.2017.35.15_suppl.9054.Peer-Reviewed Original ResearchPrimary endpointInterim analysisStage IV squamous cell lung cancerResponse rateSquamous cell lung cancerNational Clinical Trials NetworkSingle-arm phase II trialArm phase II trialGrade 3 AEsGrade 5 eventsPIK3CA-mutant tumorsPrimary analysis populationPhase II studyPhase II trialOverall survival dataCell lung cancerPlatinum-based therapyPrimary platinum-based therapyClinical Trials NetworkClinical trial informationPI3K mutationsPI3K pathwayEligible ptsMedian PFSStable diseaseA phase II study of palbociclib (P) for previously treated cell cycle gene alteration positive patients (pts) with stage IV squamous cell lung cancer (SCC): Lung-MAP sub-study SWOG S1400C.
Edelman M, Redman M, Albain K, McGary E, Rafique N, Petro D, Waqar S, Miao J, Griffin K, Papadimitrakopoulou V, Kelly K, Gandara D, Herbst R. A phase II study of palbociclib (P) for previously treated cell cycle gene alteration positive patients (pts) with stage IV squamous cell lung cancer (SCC): Lung-MAP sub-study SWOG S1400C. Journal Of Clinical Oncology 2017, 35: 9056-9056. DOI: 10.1200/jco.2017.35.15_suppl.9056.Peer-Reviewed Original ResearchStage IV squamous cell lung cancerDisease control rateAdverse eventsResponse rateCCND1 amplificationGrade 3 treatment-related adverse eventsPhase II/III trialsCell cycle gene alterationsPrior platinum-based chemotherapyGrade 4 adverse eventsTreatment-related adverse eventsSquamous cell lung cancerGene alterationsPhase II studyPhase II trialPlatinum-based chemotherapyCDK 4/6 inhibitorsCell lung cancerNormal organ functionMedian PFSPrimary endpointII studyII trialIII trialsPositive patientsPhase 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
Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial
Goldberg SB, Gettinger SN, Mahajan A, Chiang AC, Herbst RS, Sznol M, Tsiouris AJ, Cohen J, Vortmeyer A, Jilaveanu L, Yu J, Hegde U, Speaker S, Madura M, Ralabate A, Rivera A, Rowen E, Gerrish H, Yao X, Chiang V, Kluger HM. Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2016, 17: 976-983. PMID: 27267608, PMCID: PMC5526047, DOI: 10.1016/s1470-2045(16)30053-5.Peer-Reviewed Original ResearchConceptsProgressive brain metastasesUntreated brain metastasesBrain metastasis responseYale Cancer CenterBrain metastasesPhase 2 trialCell lung cancerAdverse eventsMetastasis responseCancer CenterLung cancerMelanoma cohortGrade 3 colitisGrade 3 fatigueGrade 3 pneumonitisPD-1 axisAcute kidney injuryNeurological adverse eventsPD-1 inhibitorsAcceptable safety profilePD-L1 expressionSystemic immunotherapyKidney injuryPrimary endpointNSCLC cohort
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
Phase 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
2011
Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial
Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. The Lancet 2011, 377: 1846-1854. PMID: 21621716, PMCID: PMC4134127, DOI: 10.1016/s0140-6736(11)60545-x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDouble-Blind MethodErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedProportional Hazards ModelsProtein Kinase InhibitorsQuinazolinesSurvival RateVascular Endothelial Growth Factor AConceptsPhase 3 trialBevacizumab groupCell lung cancerAdverse eventsOverall survivalRefractory NSCLCPrimary endpointLung cancerControl groupComputer-generated randomisation sequenceGrade 5 adverse eventsStandard first-line chemotherapyCalculation of incidenceEfficacy of bevacizumabArterial thromboembolic eventsFirst-line chemotherapyMedian overall survivalObjective response rateSerious adverse eventsAddition of bevacizumabFirst-line treatmentPhase 1/2 trialProgression-free survivalToxic effect profilesActivity of erlotinib
2010
Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials
Zinner RG, Novello S, Peng G, Herbst R, Obasaju C, Scagliotti G. Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials. Clinical Lung Cancer 2010, 11: 126-131. PMID: 20199979, DOI: 10.3816/clc.2010.n.017.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedMulticenter Studies as TopicNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPemetrexedRetrospective StudiesSurvival RateTreatment OutcomeConceptsNonsquamous histologyProgression-free survivalSquamous histologyOverall survivalLung cancerStage IIIB/IV non-small cell lung cancerResponse rateStage IIIB/IV NSCLCNon-small cell lung cancerRecent phase III studyPemetrexed-treated patientsChemotherapy-naive patientsPhase II studyPhase II trialPhase III studyCell lung cancerCarboplatin areaNSCLC histologyPlatinum doubletsII trialPrimary endpointII studyIII studyPerformance statusTreatment arms