2023
Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer
Rudin C, Cervantes A, Dowlati A, Besse B, Ma B, Costa D, Schmid P, Heist R, Villaflor V, Spahn J, Li S, Cha E, Riely G, Gettinger S. Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer. ESMO Open 2023, 8: 101160. PMID: 36871392, PMCID: PMC10163154, DOI: 10.1016/j.esmoop.2023.101160.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsLung cancerClinical activityEpidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) efficacyGrade 3 treatment-related adverse eventsEGFR TKI-naive patientsMedian progression-free survivalEGFR mutation-positive NSCLCAdvanced EGFR mutation-positive NSCLCTyrosine kinase inhibitor efficacyDurable clinical activityTolerable safety profileMedian overall survivalMedian response durationObjective response ratePhase Ib trialSerious adverse eventsProgression-free survivalStage 2 patientsMutation-positive NSCLCEGFR-mutant NSCLCTKI-naive patientsAtezolizumab 1200
2022
Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC
Kim DW, Gadgeel S, Gettinger SN, Riely GJ, Oxnard GR, Mekhail T, Schmid P, Dowlati A, Heist RS, Wozniak AJ, Singh J, Cha E, Spahn J, Ou SI. Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC. JTO Clinical And Research Reports 2022, 3: 100367. PMID: 35875467, PMCID: PMC9304608, DOI: 10.1016/j.jtocrr.2022.100367.Peer-Reviewed Original ResearchTreatment-related adverse eventsPhase 1b studyAdverse eventsPositive NSCLCAntitumor activityGrade 3 treatment-related adverse eventsPreferred first-line treatment optionAdvanced ALK-positive NSCLCMedian progression-free survivalStage IIIB/IVFirst-line treatment optionDose of alectinibIIIB/IVImmune checkpoint inhibitorsMedian overall survivalObjective response rateProgression-free survivalDose-limiting toxicityALK-positive NSCLCAtezolizumab 1200Checkpoint inhibitorsStarting doseMedian durationOverall survivalCombination regimens
2021
458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Schoenfeld A, Lee S, Paz-Ares L, Doger B, Gettinger S, Haefliger S, Orcurto A, Sukari A, Papa S, Rodriguez Moreno J, Finckenstein F, Jagasia M, Fiaz R, Sulur G, Chen G, Gontcharova V, He K. 458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC). 2021, a486-a487. DOI: 10.1136/jitc-2021-sitc2021.458.Peer-Reviewed Original ResearchNon-small cell lung cancerImmune checkpoint inhibitorsAdvanced non-small cell lung cancerDurable responsesPrior linesSystemic therapyMetastatic non-small cell lung cancerFirst-line immune checkpoint inhibitorsPrior immune checkpoint inhibitorsT cell receptor repertoireExpected safety profileExploratory biomarker analysisPhase 2 multicenterObjective response rateOpen-label studyComplete metabolic responsePD-L1 expressionMajority of patientsCell lung cancerTCR repertoire analysisOncogene-directed therapyBest percentage changeInstitutional review boardWarrants further investigationInformed consent formBrigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials.
Gettinger S, Huber R, Kim D, Bazhenova L, Hansen K, Tiseo M, Langer C, Paz-Ares L, West H, Reckamp K, Weiss G, Smit E, Hochmair M, Kim S, Ahn M, Kim E, Groen H, Pye J, Vranceanu F, Camidge D. Brigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials. Journal Of Clinical Oncology 2021, 39: 9071-9071. DOI: 10.1200/jco.2021.39.15_suppl.9071.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalPhase 1/2 studyIndependent review committeeArm A/BPhase 2 trialOverall survivalPhase 1/2Arm AKaplan-MeierRefractory non-small cell lung cancerMetastatic non-small cell lung cancerHigher median progression-free survivalMedian progression-free survivalTreatment-emergent adverse eventsALK tyrosine kinase inhibitorsKinase inhibitorsBaseline brain metastasesObjective response rateOpen-label trialNew safety signalsCell lung cancerDuration of responseTreatment of patientsLong-term efficacySecond-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆
Spigel D, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Aranda N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Luft A, Wolf J, Antonia S, Nakagawa K, Fairchild J, Baudelet C, Pandya D, Doshi P, Chang H, Reck M. Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆. Annals Of Oncology 2021, 32: 631-641. PMID: 33539946, DOI: 10.1016/j.annonc.2021.01.071.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerRelapsed Small-Cell Lung CancerOverall survivalLung cancerMedian progression-free survivalTreatment-related adverse eventsBaseline lactate dehydrogenaseBaseline liver metastasesSecond-line nivolumabSelect baseline characteristicsTrials of nivolumabImproved overall survivalObjective response rateCombined positive scoreNew safety signalsProgression-free survivalPlatinum-based chemotherapyPrimary endpointAdverse eventsBaseline characteristicsLiver metastasesMedian durationStandard chemotherapySurvival benefitUnacceptable toxicity
2020
Bempegaldesleukin (NKTR-214) plus Nivolumab in Patients with Advanced Solid Tumors: Phase I Dose-Escalation Study of Safety, Efficacy, and Immune Activation (PIVOT-02)
Diab A, Tannir NM, Bentebibel SE, Hwu P, Papadimitrakopoulou V, Haymaker C, Kluger HM, Gettinger SN, Sznol M, Tykodi SS, Curti BD, Tagliaferri MA, Zalevsky J, Hannah AL, Hoch U, Aung S, Fanton C, Rizwan A, Iacucci E, Liao Y, Bernatchez C, Hurwitz ME, Cho DC. Bempegaldesleukin (NKTR-214) plus Nivolumab in Patients with Advanced Solid Tumors: Phase I Dose-Escalation Study of Safety, Efficacy, and Immune Activation (PIVOT-02). Cancer Discovery 2020, 10: 1158-1173. PMID: 32439653, DOI: 10.1158/2159-8290.cd-19-1510.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellFemaleGene Expression Regulation, NeoplasticHumansImmune Checkpoint InhibitorsImmunotherapyInterleukin-2Kidney NeoplasmsLung NeoplasmsLymphocyte CountLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNivolumabPolyethylene GlycolsProgrammed Cell Death 1 ReceptorTreatment OutcomeYoung AdultConceptsTreatment-related adverse eventsAdvanced solid tumorsPD-L1 statusSolid tumorsGrade 3/4 treatment-related adverse eventsPD-1/PD-L1 blockadeCommon treatment-related adverse eventsPhase I dose-escalation trialPoor prognostic risk factorsTotal objective response rateI dose-escalation studyI dose-escalation trialLongitudinal tumor biopsiesPD-L1 blockadeT-cell enhancementTreatment-related deathsObjective response ratePhase II doseDose-escalation studyDose-escalation trialDose-limiting toxicityFlu-like symptomsPrognostic risk factorsTumor-infiltrating lymphocytesCytotoxicity of CD8
2019
Brigatinib in Crizotinib-Refractory ALK+ NSCLC: 2-Year Follow-up on Systemic and Intracranial Outcomes in the Phase 2 ALTA Trial
Huber RM, Hansen KH, Paz-Ares Rodríguez L, West HL, Reckamp KL, Leighl NB, Tiseo M, Smit EF, Kim DW, Gettinger SN, Hochmair MJ, Kim SW, Langer CJ, Ahn MJ, Kim ES, Kerstein D, Groen HJM, Camidge DR. Brigatinib in Crizotinib-Refractory ALK+ NSCLC: 2-Year Follow-up on Systemic and Intracranial Outcomes in the Phase 2 ALTA Trial. Journal Of Thoracic Oncology 2019, 15: 404-415. PMID: 31756496, DOI: 10.1016/j.jtho.2019.11.004.Peer-Reviewed Original ResearchConceptsProgression-free survivalObjective response rateIntracranial objective response rateOverall survivalIntracranial PFSResponse rateEnd pointIntracranial responseBrain lesionsCentral nervous system metastasesSolid Tumors version 1.1Intracranial progression-free survivalCrizotinib-refractory patientsMedian overall survivalNervous system metastasesNew safety findingsPrimary end pointSecondary end pointsTarget lesion responseResponse Evaluation CriteriaIndependent review committeeDepth of responseImportant end pointIntracranial outcomesOral brigatinibLBA1 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 Squibb1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial
Lee D, Kim D, Camidge D, Langer C, Huber R, Tiseo M, West H, Groen H, Reckamp K, Hochmair M, Leighl N, Hansen K, Gettinger S, Paz-Ares L, Kim E, Smit E, Kim S, Ni Q, Zhang P, Ahn M. 1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial. Annals Of Oncology 2019, 30: v634-v635. DOI: 10.1093/annonc/mdz260.065.Peer-Reviewed Original ResearchBristol-Myers SquibbCNS metastasesTakeda Pharmaceutical Company LimitedBoehringer IngelheimARIAD PharmaceuticalsClovis OncologyRoche/GenentechEli LillyMerck SharpBaseline CNS metastasesIntracranial objective responseMost common gradeObjective response rateProgression-free survivalDuration of responseIndependent review committeeNon-Asian patientsPierre FabreMedian DoRMedian iPFSMedian PFSRECIST v1.1Objective responseOverall survivalMedian ageA phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors.
Chesney J, Lutzky J, Thomas S, Nieva J, Munoz Couselo E, Martin-Liberal J, Rodriguez-Moreno J, Cacovean A, Li H, Fardis M, Gettinger S. A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors. Journal Of Clinical Oncology 2019, 37: tps2648-tps2648. DOI: 10.1200/jco.2019.37.15_suppl.tps2648.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsPrior immune checkpoint inhibitorsObjective response rateTIL therapyAdoptive cell therapySystemic therapyCohort 1Cohort 3RECIST 1.1Metastatic melanomaNeck cancerPhase 2 multicenterPrior systemic therapyDurable complete responseOpen-label studyPhase II studyMetastatic melanoma patientsCo-primary endpointsHigh mutational burdenAutologous tumorECOG PSMeasurable diseaseAcceptable toxicityCheckpoint inhibitorsImmunogenic tumors
2018
FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC
Spigel DR, Chaft JE, Gettinger S, Chao BH, Dirix L, Schmid P, Chow LQM, Hicks RJ, Leon L, Fredrickson J, Kowanetz M, Sandler A, Funke R, Rizvi NA. FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC. Journal Of Thoracic Oncology 2018, 13: 1733-1742. PMID: 29775807, PMCID: PMC7455890, DOI: 10.1016/j.jtho.2018.05.004.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-L1 expressionAdverse eventsCohort 1Immune cell PD-L1 expressionInvestigator-assessed objective response ratePhase II open-label studyResponse rateIC PD-L1 expressionTumor cellsBaseline tumor samplesOpen-label studyPhase II studyProgression-free survivalResponse Evaluation CriteriaDuration of responseAtezolizumab monotherapyAdvanced NSCLCBrain metastasesMonotherapy studiesPrimary endpointSecondary endpointsII studyOverall survivalBrigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2018, 379: 2027-2039. PMID: 30280657, DOI: 10.1056/nejmoa1810171.Peer-Reviewed Original ResearchConceptsProgression-free survivalALK-positive NSCLCAdvanced ALK-positive NSCLCObjective response rateFirst interim analysisALK inhibitorsLung cancerIntracranial responseInterim analysisNext-generation anaplastic lymphoma kinase (ALK) inhibitorResponse rateConfirmed objective response rateEnd pointSmall cell lung cancerBlinded independent central reviewAnaplastic lymphoma kinase inhibitorsEfficacy of brigatinibPrimary end pointSecondary end pointsPhase 3 trialALK-Positive NonCell lung cancerIndependent central reviewNew safety concernsCrizotinib groupSafety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study
Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fassò M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. European Journal Of Cancer 2018, 101: 201-209. PMID: 30077125, DOI: 10.1016/j.ejca.2018.06.031.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsBaseline PD-L1 expressionObjective response ratePD-L1 expressionPD-L1Immune cellsGrade treatment-related adverse eventsSurvival rateCell lung cancer cohortLong-term clinical benefitTumor-infiltrating immune cellsTumor cellsPhase IPrevious systemic therapySingle-agent atezolizumabCell lung cancerExploratory subgroup analysisLung cancer cohortAtezolizumab monotherapyAdverse eventsDurable responsesMedian durationSystemic therapyAnticancer immunityPD-1Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non–small-cell lung cancer
Liu SV, Camidge DR, Gettinger SN, Giaccone G, Heist RS, Hodi FS, Ready NE, Zhang W, Wallin J, Funke R, Waterkamp D, Foster P, Iizuka K, Powderly J. Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non–small-cell lung cancer. European Journal Of Cancer 2018, 101: 114-122. PMID: 30053670, DOI: 10.1016/j.ejca.2018.06.033.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeutropeniaSurvival AnalysisTime FactorsTreatment OutcomeConceptsObjective response rateProgression-free survivalCell lung cancerOverall survivalLung cancerAnti-programmed death ligand 1 antibodyGrade III/IV adverse eventsConfirmed objective response rateMedian progression-free survivalPlatinum-based doublet chemotherapyStandard first-line therapyDeath ligand 1 antibodyCell death protein 1Availability of immunotherapyMedian overall survivalFirst-line therapyLigand 1 antibodyDeath protein 1Actionable gene alterationsLong-term survivalDoublet chemotherapyImmunotherapy combinationsNab-PacNab-paclitaxelAdverse eventsNivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
Gettinger S, Hellmann MD, Chow LQM, Borghaei H, Antonia S, Brahmer JR, Goldman JW, Gerber DE, Juergens RA, Shepherd FA, Laurie SA, Young TC, Li X, Geese WJ, Rizvi N. Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. Journal Of Thoracic Oncology 2018, 13: 1363-1372. PMID: 29802888, DOI: 10.1016/j.jtho.2018.05.015.Peer-Reviewed Original ResearchConceptsAdvanced EGFR-mutant NSCLCEGFR-mutant NSCLCTreatment-related grade 3 toxicitiesEGFR-mutant advanced NSCLCProgression-free survival ratesEGFR T790M mutationEGFR tyrosine kinase inhibitorsGrade 3 toxicityObjective response rateTKI-naive patientsCompound EGFR mutationsT790M mutationTyrosine kinase inhibitorsImmune-related responsesInvestigator recordsAdvanced NSCLCDurable responsesUnacceptable toxicityComplete responseFourth patientDisease progressionEGFR mutationsMutant NSCLCTumor biopsiesNivolumab
2017
Phase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1–Selected Advanced Non–Small-Cell Lung Cancer (BIRCH)
Peters S, Gettinger S, Johnson ML, Jänne PA, Garassino MC, Christoph D, Toh CK, Rizvi NA, Chaft JE, Carcereny Costa E, Patel JD, Chow LQM, Koczywas M, Ho C, Früh M, van den Heuvel M, Rothenstein J, Reck M, Paz-Ares L, Shepherd FA, Kurata T, Li Z, Qiu J, Kowanetz M, Mocci S, Shankar G, Sandler A, Felip E. Phase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1–Selected Advanced Non–Small-Cell Lung Cancer (BIRCH). Journal Of Clinical Oncology 2017, 35: jco.2016.71.947. PMID: 28609226, PMCID: PMC5562171, DOI: 10.1200/jco.2016.71.9476.Peer-Reviewed Original ResearchConceptsMedian overall survivalOverall survivalImmune cellsPD-L1Tumor cellsLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerTumor-infiltrating immune cellsEnd pointEfficacy of atezolizumabEfficacy-evaluable patientsMethods Eligible patientsObjective response ratePrimary end pointSecondary end pointsLines of therapyPD-L1 expressionPD-L1 statusPhase II trialProgression-free survivalDeath ligand 1Cell lung cancerKRAS mutation statusAtezolizumab monotherapyBrigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial.
Ahn M, Camidge D, Tiseo M, Reckamp K, Holmskov Hansen K, Kim S, Huber R, West H, Groen H, Hochmair M, Leighl N, Gettinger S, Langer C, Paz-Ares L, Smit E, Kim E, Reichmann W, Kerstein D, Kim D. Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial. Journal Of Clinical Oncology 2017, 35: e20503-e20503. DOI: 10.1200/jco.2017.35.15_suppl.e20503.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response rateRandomized phase 2 trialPhase 2 trialAdverse eventsBrain metastasesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesPulmonary adverse eventsPhase 1/2 trialCell lung cancerRECIST v1.1Primary endpointNSCLC patientsMedian ageAcceptable safetyLung cancerDisease progressionDose reductionDose levelsResponse rateBrigatinibActivity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status.
Bazhenova L, Hodgson J, Langer C, Simon G, Gettinger S, Ou S, Reckamp K, West H, Chiappori A, Koh H, Molina J, Shaw A, Patel J, Favaro J, Haney J, Reichmann W, Kerstein D, Rivera V, Camidge D. Activity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status. Journal Of Clinical Oncology 2017, 35: 9065-9065. DOI: 10.1200/jco.2017.35.15_suppl.9065.Peer-Reviewed Original ResearchSecondary ALK mutationsNSCLC ptsALK mutationsALK fusionMutation statusObjective response ratePlasma samplesALK mutation statusSelective ALK inhibitorNSCLC patientsClinical activityEvaluable samplesALK inhibitorsResistance patternsSecondary resistanceTherapeutic implicationsComplex mutation patternsResponse rateBrigatinibPlasma specimensWild-type ALKALKTrialsGood responseMutation patternsDesign of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Tiseo M, Popat S, Gettinger S, Peters S, Haney J, Kerstein D, Camidge D. Design of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: tps9098-tps9098. DOI: 10.1200/jco.2017.35.15_suppl.tps9098.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalObjective response rateRandomized phase 3 trialPhase 3 trialPrimary endpointTKI therapyPositive non-small cell lung cancerAdvanced anaplastic lymphoma kinaseNext-generation ALK inhibitorsRandomized phase 2 trialPrior TKI therapySafety/tolerabilityPhase 1/2 trialPhase 2 trialKaplan-Meier methodCell lung cancerDuration of responseIndependent review committeeLog-rank testPotent preclinical activityTyrosine kinase inhibitorsAnaplastic lymphoma kinaseNaive patientsNSCLC ptsBrigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial
Kim DW, Tiseo M, Ahn MJ, Reckamp KL, Hansen KH, Kim SW, Huber RM, West HL, Groen HJM, Hochmair MJ, Leighl NB, Gettinger SN, Langer CJ, Paz-Ares Rodríguez LG, Smit EF, Kim ES, Reichmann W, Haluska FG, Kerstein D, Camidge DR. Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. Journal Of Clinical Oncology 2017, 35: jco.2016.71.590. PMID: 28475456, DOI: 10.1200/jco.2016.71.5904.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAnaplastic Lymphoma KinaseAntineoplastic AgentsBrain NeoplasmsCarcinoma, Non-Small-Cell LungCoughCrizotinibDiarrheaDisease ProgressionDisease-Free SurvivalFemaleHeadacheHumansLung NeoplasmsMaleMiddle AgedNauseaOrganophosphorus CompoundsProspective StudiesPyrazolesPyridinesPyrimidinesReceptor Protein-Tyrosine KinasesRetreatmentTreatment OutcomeYoung AdultConceptsObjective response rateProgression-free survivalBrain metastasesArm AAdverse eventsLung cancerInvestigator-assessed median progression-free survivalCommon treatment-emergent adverse eventsPositive non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalMulticenter phase II trialNext-generation ALK inhibitorsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesCrizotinib-treated patientsMeasurable brain metastasesPulmonary adverse eventsPrimary end pointPhase II trialCell lung cancerALK-positive NSCLCAnaplastic lymphoma kinase (ALK) geneAnaplastic lymphoma kinase