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
2013
BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC).
Papadimitrakopoulou V, Wistuba I, Lee J, Tsao A, Kalhor N, Fossella F, Heymach J, Alden C, Gettinger S, Coombes K, Saintigny P, Tang X, Duffield E, Boyer J, Davis S, Powis G, Mauro D, Rubin E, Hong W, Herbst R. BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8118-tps8118. DOI: 10.1200/jco.2013.31.15_suppl.tps8118.Peer-Reviewed Original ResearchNon-small cell lung cancerDisease control rateEvaluable ptsKRAS statusPredictive biomarkersRefractory non-small cell lung cancerAdvanced non-small cell lung cancerEML4/ALK translocationsPhase II clinical trialStage 1Lung Cancer EliminationOptimal patient selectionCell lung cancerEffective therapeutic strategyMEK inhibitor selumetinibUnmet medical needBiomarkers of resistanceAKT inhibitor MKPersonalized medicine approachPI3K/AktStage 2NCSLC patientsNSCLC ptsPatient selectionNSCLC treatment
2009
Phase II randomized study of biomarker-directed treatment for non-small cell lung cancer (NSCLC): The BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) clinical trial program
Kim E, Herbst R, Lee J, Blumenschein G, Tsao A, Wistuba I, Alden C, Gupta S, Stewart D, Hong W. Phase II randomized study of biomarker-directed treatment for non-small cell lung cancer (NSCLC): The BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) clinical trial program. Journal Of Clinical Oncology 2009, 27: 8024-8024. DOI: 10.1200/jco.2009.27.15_suppl.8024.Peer-Reviewed Original ResearchNon-small cell lung cancerLung cancerRecurrent non-small cell lung cancerTreatment-related adverse eventsECOG PS 0Progression-free statusAdvanced lung cancerClinical trial programCell lung cancerCore needle biopsyBRAF gene mutationCyclin D1 amplificationBiomarker analysisEligible ptsEvaluable ptsPrior chemotherapyPrimary endpointAdverse eventsPS 0Pneumothorax rateTumor responseNeedle biopsyEGFR polysomyBRAF mutationsFresh biopsies
2007
Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA)
Massarelli E, Miller V, Leighl N, Rosen P, Albain K, Hart L, Melnyk O, Sternas L, Ackerman J, Herbst R. Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA). Journal Of Clinical Oncology 2007, 25: 7627-7627. DOI: 10.1200/jco.2007.25.18_suppl.7627.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPartial responsePerformance statusGrade 3Prior treatmentSquamous cell lung cancerEmergent adverse eventsSignificant bleeding diathesisECOG performance statusObjective response ratePhase II studyProgression-free survivalSingle-agent activityDuration of responseMulti-center trialMost common reasonsInterim futility analysisVEGF receptor inhibitorQuality of lifeBone painEvaluable ptsFebrile neutropeniaMeasurable diseaseBrain metastasesAdverse events