2019
LBA1 Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial
Camidge R, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Ni Q, Zhang P, Popat S. LBA1 Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial. Annals Of Oncology 2019, 30: ix195-ix196. DOI: 10.1093/annonc/mdz446.Peer-Reviewed Original ResearchBrain metastasesPFS eventsTakeda Pharmaceutical Company LimitedPrior chemotherapyBoehringer IngelheimInterim analysisARIAD PharmaceuticalsGuardant HealthPFS HREli LillyBlinded independent review committeeClovis OncologyAdditional efficacy dataAsymptomatic CNS metastasesBaseline brain metastasesECOG PS 0Measurable brain metastasesObjective response rateProgression-free survivalSecond interim analysisPatient-reported qualityDuration of responseIndependent review committeeRoche/GenentechBristol-Myers SquibbO1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L
Yang J, Kim H, Ahn M, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Haney J, Kerstein D, Popat S, Camidge D. O1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L. Annals Of Oncology 2019, 30: vi83. DOI: 10.1093/annonc/mdz339.006.Peer-Reviewed Original ResearchIntracranial ORRInterim analysisPFS eventsBlinded independent review committeeAsymptomatic CNS metastasesBaseline brain metastasesMost common gradeSecondary efficacy endpointsFirst interim analysisIndependent review committeeCNS metastasisMedian iPFSMedian PFSPrior chemotherapyAdvanced diseaseEfficacy endpointPrimary endpointBrain metastasesData cutoffSystemic therapyALK-TKIMedian ageMulticenter studyCommon gradeCrizotinib
2012
A randomized discontinuation phase II trial of ridaforolimus in non-small cell lung cancer (NSCLC) patients with KRAS mutations.
Riely G, Brahmer J, Planchard D, Crinò L, Doebele R, Mas Lopez L, Gettinger S, Schumann C, Li X, Atkins B, Ebbinghaus S, Rosell R. A randomized discontinuation phase II trial of ridaforolimus in non-small cell lung cancer (NSCLC) patients with KRAS mutations. Journal Of Clinical Oncology 2012, 30: 7531-7531. DOI: 10.1200/jco.2012.30.15_suppl.7531.Peer-Reviewed Original ResearchProgression-free survivalStable diseaseKRAS mutationsAdvanced NSCLCStage IIIB/IV non-small cell lung cancerResponse rateNon-small cell lung cancer patientsNon-small cell lung cancerMedian progression-free survivalProlonged progression-free survivalCell lung cancer patientsAvailable standard treatmentMucositis/stomatitisPhase II trialAdvanced endometrial cancerCell lung cancerLung cancer patientsOverall response rateSoft tissue sarcomasDays/week scheduleKRAS-mutant NSCLCInhibitor of mTORMedian OSOral ridaforolimusPrior chemotherapy
2007
A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases
Mekhail T, Gettinger S, Blumenschein G, Axelrod R, Haigentz M, Guarino M, Cahill A, Spigel D, Greco F. A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases. Journal Of Clinical Oncology 2007, 25: 7724-7724. DOI: 10.1200/jco.2007.25.18_suppl.7724.Peer-Reviewed Original ResearchSmall cell lung cancerBrain metastasesBrain metsSCLC patientsRelapse groupVNP40101MGrade 3Refractory small cell lung cancerNon-hematologic toxicitiesRefractory SCLC patientsPhase II trialCell lung cancerBlood-brain barrierResistant tumor cell linesECOG PSEvaluable diseaseEvaluable ptsLine chemotherapyPrior chemotherapyRelapse diseaseSensitive relapseStable diseaseII trialRECIST criteriaStarting dose