2021
Phase 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 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
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).
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
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
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 mutationsClinical and Biomarker Outcomes of the Phase II Vandetanib Study from the BATTLE Trial
Tsao AS, Liu S, Lee JJ, Alden CM, Blumenschein GR, Herbst R, Davis SE, Kim E, Lippman S, Heymach J, Tran H, Tang X, Wistuba I, Hong WK. Clinical and Biomarker Outcomes of the Phase II Vandetanib Study from the BATTLE Trial. Journal Of Thoracic Oncology 2013, 8: 658-661. PMID: 23584298, PMCID: PMC5118909, DOI: 10.1097/jto.0b013e31828d08ae.Peer-Reviewed Original ResearchMeSH KeywordsAcute-Phase ProteinsAgedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleGene AmplificationGenes, erbB-1HumansInterleukin-9Kaplan-Meier EstimateLipocalin-2LipocalinsLung NeoplasmsMaleMiddle AgedMutationPiperidinesProportional Hazards ModelsProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTNF-Related Apoptosis-Inducing LigandConceptsDisease control rateWorse OSShorter PFSControl rateMutation patientsDual epidermal growth factor receptorVascular endothelial growth factor receptor inhibitionLung Cancer Elimination (BATTLE) trialNeutrophil gelatinase-associated lipocalinCell lung cancer patientsGrowth factor receptor inhibitionPhase II trialGelatinase-associated lipocalinLung cancer patientsTumor core biopsiesSerum biomarker analysisEGFR mutation patientsEpidermal growth factor receptorEGFR gene amplificationApoptosis-inducing ligandGrowth factor receptorMedian PFSOS benefitEpidermal growth factor receptor tyrosine kinaseII trial
2011
The BATTLE Trial: Personalizing Therapy for Lung Cancer
Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR, Tsao A, Stewart DJ, Hicks ME, Erasmus J, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE Trial: Personalizing Therapy for Lung Cancer. Cancer Discovery 2011, 1: 44-53. PMID: 22586319, PMCID: PMC4211116, DOI: 10.1158/2159-8274.cd-10-0010.Peer-Reviewed Original ResearchConceptsLung cancer patientsCancer patientsNon-small cell lung cancer patientsLung Cancer Elimination (BATTLE) trialCell lung cancer patientsDisease control rateCore needle biopsy specimensLung cancer clinical trialsSpecific patient populationsLung cancer therapyNeedle biopsy specimensCancer clinical trialsRelevant molecular biomarkersKRAS patientsNSCLC patientsPatient populationRandomization periodControl rateLaboratory findingsLung cancerBiopsy specimensClinical trialsTargeted therapyBATTLE TrialIndividualized treatment
2008
Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine
Xian Zhou, Suyu Liu, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine. Clinical Trials 2008, 5: 181-193. PMID: 18559407, PMCID: PMC5481999, DOI: 10.1177/1740774508091815.Peer-Reviewed Original ResearchConceptsDisease control rateBiomarker profilesControl rateTrial designRandomization ratesEffective agentLung cancerAdvanced stage non-small cell lung cancerStage non-small cell lung cancerNon-small cell lung cancerBaseline biopsy samplesPatient's biomarker profileCell lung cancerEarly stopping ruleEvaluable patientsPrimary endpointMore patientsPersonalized medicineAdaptive randomization designEffective treatmentBiomarker assessmentBiopsy samplesPatientsBayesian adaptive designIndividual tumorsOverview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies
Vermorken JB, Herbst RS, Leon X, Amellal N, Baselga J. Overview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies. Cancer 2008, 112: 2710-2719. PMID: 18481809, DOI: 10.1002/cncr.23442.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Squamous CellCetuximabCisplatinClinical Trials as TopicDrug Resistance, NeoplasmHead and Neck NeoplasmsHumansMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRetrospective StudiesSurvival AnalysisTreatment OutcomeConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaMetastatic SCCHNPlatinum therapyRetrospective studyCell carcinomaEpidermal growth factor receptor (EGFR) inhibitor cetuximabActivity of cetuximabCarboplatin-based chemotherapyCetuximab-based treatmentCisplatin/carboplatinDisease control rateMedian overall survivalSecond-line therapySecond-line treatmentEfficacy of cetuximabPlatinum-based therapyOverall response ratePlatinum failureOverall survivalMedian timeProlong survivalProspective studyControl rateEfficacy data