2023
ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC).
Padda S, Redman M, Gerber D, Stinchcombe T, Waqar S, Leal T, Minichiello K, Reckamp K, Herbst R, Borghaei H, Brahmer J, Gray J, Kelly K, Ramalingam S, Neal J. ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: tps9143-tps9143. DOI: 10.1200/jco.2023.41.16_suppl.tps9143.Peer-Reviewed Original ResearchNon-squamous non-small cell lung cancerTarget sample sizeKRAS G12C inhibitorsCohort 1Eligible ptsBrain metastasesG12C inhibitorsPhase 2 open-label studyNon-small cell lung cancerAsymptomatic brain metastasesOpen-label studyPhase II studyUntreated brain metastasesCell lung cancerDuration of responsePresence of TP53Wild-type TP53Oral dailySecondary endpointsII studySystemic treatmentAccrual targetLung cancerCohort 2Clinical activity
2022
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).
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 approachCOAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non–Small-Cell Lung Cancer
Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2022, 40: 3383-3393. PMID: 35452273, DOI: 10.1200/jco.22.00227.Peer-Reviewed Original ResearchConceptsProgression-free survivalCell lung cancerUnresectable stage IIIConcurrent chemoradiotherapyLung cancerEastern Cooperative Oncology Group performance status 0/1Stage IIITreatment-emergent adverse eventsPerformance status 0/1Objective response ratePrimary end pointPhase II studyPhase III trialsStandard of careSignificant safety signalsPFS ratesConsolidation therapyOpen labelII studyIII trialsOverall survivalAdverse eventsDurvalumabSafety signalsMonalizumab
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 studyA 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 cancer
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 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 ageA phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G).
Owonikoko T, Redman M, Byers L, Hirsch F, Mack P, Schwartz L, Bradley J, Stinchcombe T, Leighl N, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam S, Herbst R, Papadimitrakopoulou V, Gandara D. A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G). Journal Of Clinical Oncology 2019, 37: 9022-9022. DOI: 10.1200/jco.2019.37.15_suppl.9022.Peer-Reviewed Original ResearchPrimary analysis populationSquamous cell lung cancerCell lung cancerLung cancerMedian OSMedian PFSAdverse eventsSystemic therapyStage IV squamous cell lung cancerPARP inhibitorsAdequate organ functionZubrod performance statusFrequent adverse eventsNew safety signalsPhase II studyPlatinum-sensitive diseaseSquamous lung cancerDay of registrationMedian DoREligible patientsHematologic toxicityAccrual goalII studyPerformance statusPrior linesPhase 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 rate
2017
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.
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 patients83O A phase II study of durvalumab (MEDI4736) for previously treated patients with stage IV squamous NSCLC (SqNSCLC): Lung-MAP Sub-study SWOG S1400A
Papadimitrakopoulou V, Redman M, Borghaei H, Waqar S, Robert F, Kiefer G, McDonough S, Herbst R, Kelly K, Gandara D. 83O A phase II study of durvalumab (MEDI4736) for previously treated patients with stage IV squamous NSCLC (SqNSCLC): Lung-MAP Sub-study SWOG S1400A. Annals Of Oncology 2017, 28: ii29. DOI: 10.1093/annonc/mdx091.003.Peer-Reviewed Original Research
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 therapyPhase II Trial of S-1 as Second-Line Therapy in Patients with Advanced Non-small Cell Lung Cancer
Govindan R, Morgensztern D, Kommor MD, Herbst RS, Schaefer P, Gandhi J, Saito K, Zergebel C, Schiller J. Phase II Trial of S-1 as Second-Line Therapy in Patients with Advanced Non-small Cell Lung Cancer. Journal Of Thoracic Oncology 2011, 6: 790-795. PMID: 21325974, DOI: 10.1097/jto.0b013e3182103b51.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntimetabolites, AntineoplasticCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDrug CombinationsFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingOxonic AcidPrognosisSalvage TherapySurvival RateTegafurConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerCell lung cancerOverall response rateLung cancerAdvanced stage non-small cell lung cancerCommon treatment-related side effectsStage non-small cell lung cancerResponse rateMulticenter phase II studyTreatment-related side effectsDisease control rateLines of chemotherapyPhase II studyPrimary end pointSecond-line therapyPhase II trialProgression-free survivalNon-Asian populationsOral fluoropyrimidineOral SStable diseaseII trialII studyHistologic subtype
2010
Phase II Study of Vinorelbine and Docetaxel in the Treatment of Advanced Non–Small-Cell Lung Cancer as Frontline and Second-Line Therapy
William WN, Khuri FR, Fossella FV, Glisson BS, Zinner RG, Lee JJ, Herbst RS, Lippman SM, Kim ES. Phase II Study of Vinorelbine and Docetaxel in the Treatment of Advanced Non–Small-Cell Lung Cancer as Frontline and Second-Line Therapy. American Journal Of Clinical Oncology 2010, 33: 148-152. PMID: 19687727, PMCID: PMC5118944, DOI: 10.1097/coc.0b013e318199fb99.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDocetaxelFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingSalvage TherapySurvival RateTaxoidsTreatment OutcomeVinblastineVinorelbineConceptsCell lung cancerLung cancerGrade 3Advanced non-small cell lung cancerNon-small cell lung cancerCommon grade 3Experienced febrile neutropeniaFirst-line settingMedian overall survivalNausea/vomitingSecond-line patientsSecond-line settingSecond-line therapyPhase 2 studyPhase II studySingle-agent chemotherapyUse of docetaxelCombination of docetaxelFrontline treatment optionFilgrastim supportNonplatinum agentsFebrile neutropeniaNonhematologic toxicitySalvage therapyII studyComparison 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
2009
Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small cell lung cancer (NSCLC): A randomized, double-blind phase III trial (ZODIAC)
Herbst R, Sun Y, Korfee S, Germonpré P, Saijo N, Zhou C, Wang J, Langmuir P, Kennedy S, Johnson B. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small cell lung cancer (NSCLC): A randomized, double-blind phase III trial (ZODIAC). Journal Of Clinical Oncology 2009, 27: cra8003-cra8003. DOI: 10.1200/jco.2009.27.18_suppl.cra8003.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalObjective response ratePhase III trialsAddition of vandetanibVandetanib armIII trialsOverall survivalStage IIIB/IV non-small cell lung cancerAdvanced non-small cell lung cancerDouble-blind phase III trialPrevious first-line chemotherapyRandomized phase II studyDaily oral inhibitorSecond-line treatmentAdverse event profileDeterioration of symptomsFirst-line chemotherapyPhase II studyCell lung cancerCommon AEsPFS prolongationII studySecondary endpointsBaseline characteristicsClassification by Mass Spectrometry Can Accurately and Reliably Predict Outcome in Patients with Non-small Cell Lung Cancer Treated with Erlotinib-Containing Regimen
Salmon S, Chen H, Chen S, Herbst R, Tsao A, Tran H, Sandler A, Billheimer D, Shyr Y, Lee JW, Massion P, Brahmer J, Schiller J, Carbone D, Dang TP. Classification by Mass Spectrometry Can Accurately and Reliably Predict Outcome in Patients with Non-small Cell Lung Cancer Treated with Erlotinib-Containing Regimen. Journal Of Thoracic Oncology 2009, 4: 689-696. PMID: 19404214, PMCID: PMC3563261, DOI: 10.1097/jto.0b013e3181a526b3.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCarcinoma, Non-Small-Cell LungCase-Control StudiesCohort StudiesErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalPleural Effusion, MalignantPrognosisQuinazolinesReproducibility of ResultsSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationSurvival RateTreatment OutcomeConceptsNon-small cell lung cancerCell lung cancerLung cancerRefractory non-small cell lung cancerPhase I/II studyUnivariate Cox proportional hazards modelProgression-free survival outcomesCox proportional hazards modelOutcomes of patientsCohort of patientsSelection of patientsVascular endothelial growth factorProportional hazards modelEndothelial growth factorReceptor kinase inhibitorEpidermal growth factor receptorGrowth factor receptorII studyOverall survivalPretreatment serumTreatment cohortsClinical outcomesSurvival outcomesEpidermal growth factor receptor kinase inhibitorsSuch therapyBaseline Vascular Endothelial Growth Factor Concentration as a Potential Predictive Marker of Benefit from Vandetanib in Non–Small Cell Lung Cancer
Hanrahan EO, Ryan AJ, Mann H, Kennedy SJ, Langmuir P, Natale RB, Herbst RS, Johnson BE, Heymach JV. Baseline Vascular Endothelial Growth Factor Concentration as a Potential Predictive Marker of Benefit from Vandetanib in Non–Small Cell Lung Cancer. Clinical Cancer Research 2009, 15: 3600-3609. PMID: 19447868, DOI: 10.1158/1078-0432.ccr-08-2568.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungClinical Trials, Phase II as TopicEnzyme-Linked Immunosorbent AssayHumansKaplan-Meier EstimateLung NeoplasmsMeta-Analysis as TopicPiperidinesPredictive Value of TestsQuinazolinesRandomized Controlled Trials as TopicReceptors, Vascular Endothelial Growth FactorTreatment OutcomeVascular Endothelial Growth Factor AConceptsNon-small cell lung cancerProgression-free survivalCell lung cancerAdvanced non-small cell lung cancerVandetanib monotherapyLung cancerDisease progressionVEGF levelsVEGF valuesSimilar riskRandomized phase II studyVascular endothelial growth factor concentrationsExploratory retrospective analysisPhase II studyBaseline VEGF levelsPotential predictive markerLower VEGF levelsGrowth factor concentrationsBaseline VEGFCarboplatin-paclitaxelPFS advantageII studyPredictive markerRetrospective analysisHealthy subjects
2008
Randomized Phase II Study of Vandetanib Alone or With Paclitaxel and Carboplatin as First-Line Treatment for Advanced Non–Small-Cell Lung Cancer
Heymach JV, Paz-Ares L, De Braud F, Sebastian M, Stewart DJ, Eberhardt WE, Ranade AA, Cohen G, Trigo JM, Sandler AB, Bonomi PD, Herbst RS, Krebs AD, Vasselli J, Johnson BE. Randomized Phase II Study of Vandetanib Alone or With Paclitaxel and Carboplatin as First-Line Treatment for Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2008, 26: 5407-5415. PMID: 18936474, DOI: 10.1200/jco.2008.17.3138.Peer-Reviewed Original ResearchConceptsProgression-free survivalPhase II studyRisk of progressionVandetanib monotherapyII studyOverall survivalLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalLonger progression-free survivalRandomized phase II studyShorter progression-free survivalEnd pointVascular endothelial growth factor receptorCommon adverse eventsPrimary end pointStudy end pointSquamous cell histologyEndothelial growth factor receptorCell lung cancerCNS metastasesGrowth factor receptorMonotherapy armNSCLC histology