2024
Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm A
2022
235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Reckamp K, Song Z, Gettinger S, Mitchell E, Wright J, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Conley B, Arteaga C, Harris L, O’Dwyer P, Chen A, Flaherty K. 235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. European Journal Of Cancer 2022, 174: s84-s85. DOI: 10.1016/s0959-8049(22)01023-1.Peer-Reviewed Original Research
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 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
2016
ORAL01.04: Phase II Trial of Atezolizumab for Patients with PD-L1–Selected Advanced NSCLC (BIRCH): Updated Efficacy and Exploratory Biomarker Results Topic: Medical Oncology
Wakelee H, Patel J, Heist R, Balmanoukian A, Besse B, Felip E, Costa E, Chow L, Koczywas M, Garassino M, Christoph D, Toh C, Johnson M, Chaft J, Kurata T, Qiu J, Kowanetz M, Coleman S, Mocci S, Sandler A, Gettinger S, Peters S. ORAL01.04: Phase II Trial of Atezolizumab for Patients with PD-L1–Selected Advanced NSCLC (BIRCH): Updated Efficacy and Exploratory Biomarker Results Topic: Medical Oncology. Journal Of Thoracic Oncology 2016, 11: s251-s252. DOI: 10.1016/j.jtho.2016.09.009.Peer-Reviewed Original Research
2015
Immune Checkpoint Modulation for Non–Small Cell Lung Cancer
Soria JC, Marabelle A, Brahmer JR, Gettinger S. Immune Checkpoint Modulation for Non–Small Cell Lung Cancer. Clinical Cancer Research 2015, 21: 2256-2262. PMID: 25979932, DOI: 10.1158/1078-0432.ccr-14-2959.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerCell lung cancerImmune checkpointsL1 antibodyLung cancerClinical trialsT cellsImmune-related progression-free survivalCytotoxic T-lymphocyte-associated protein 4Response rateT-lymphocyte-associated protein 4Tumor PD-L1 expressionRandomized phase II trialImmune checkpoint modulationObjective response ratePD-L1 expressionPhase II trialProgression-free survivalDeath ligand 1Immunosuppressive T cellsAdditional clinical trialsLung cancer patientsLow toxicity profileNSCLC histology
2014
A multicenter randomized phase II trial of erlotinib with and without hydroxychloroquine (HCQ) in TKI-naive patients (pts) with epidermal growth factor receptor (EGFR) mutant advanced non-small cell lung cancer (NSCLC).
Neal J, Wakelee H, Feliciano J, Goldberg S, Morgensztern D, Das M, Heist R, Lennes I, Muzikansky A, Edelman M, Gettinger S, Sequist L. A multicenter randomized phase II trial of erlotinib with and without hydroxychloroquine (HCQ) in TKI-naive patients (pts) with epidermal growth factor receptor (EGFR) mutant advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2014, 32: 8088-8088. DOI: 10.1200/jco.2014.32.15_suppl.8088.Peer-Reviewed Original Research
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
2009
A phase II trial of IPI-504 (retaspimycin hydrochloride), a novel Hsp90 inhibitor, in patients with relapsed and/or refractory stage IIIb or stage IV non-small cell lung cancer (NSCLC) stratified by EGFR mutation status
Sequist L, Gettinger S, Natale R, Martins R, Lilenbaum R, Jänne P, Gray J, Samuel T, Grayzel D, Lynch T. A phase II trial of IPI-504 (retaspimycin hydrochloride), a novel Hsp90 inhibitor, in patients with relapsed and/or refractory stage IIIb or stage IV non-small cell lung cancer (NSCLC) stratified by EGFR mutation status. Journal Of Clinical Oncology 2009, 27: 8073-8073. DOI: 10.1200/jco.2009.27.15_suppl.8073.Peer-Reviewed Original ResearchNon-small cell lung cancerPhase II trialIPI-504Anti-tumor activityStable diseaseStage IIIBII trialPartial responseStage IV non-small cell lung cancerAdvanced non-small cell lung cancerCommon related adverse eventsIndependent radiology reviewAntitumor activityRelated adverse eventsCell lung cancerEGFR mutation analysisEGFR mutation statusHeat shock protein 90 inhibitorNSCLC cell linesShock protein 90 inhibitorsMurine xenograft modelCohort expansionEligible patientsNovel Hsp90 inhibitorPrior therapy
2008
Targeted Therapy in Advanced Non-Small-Cell Lung Cancer
Gettinger S. Targeted Therapy in Advanced Non-Small-Cell Lung Cancer. Seminars In Respiratory And Critical Care Medicine 2008, 29: 291-301. PMID: 18506667, DOI: 10.1055/s-2008-1076749.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBenzenesulfonatesBevacizumabCarcinoma, Non-Small-Cell LungDrug Delivery SystemsEpidermal Growth FactorErlotinib HydrochlorideHumansIndolesLung NeoplasmsNiacinamidePhenylurea CompoundsPiperidinesProtein Kinase InhibitorsPyridinesPyrrolesQuinazolinesSignal TransductionSorafenibSunitinibTreatment OutcomeVascular Endothelial Growth Factor AConceptsPhase II trialLung cancerEpidermal growth factor receptorII trialEGFR inhibitorsSmall molecule inhibitorsAdvanced non-small cell lung cancerNon-small cell lung cancerStandard first-line chemotherapyVascular endothelial growth factor (VEGF) pathwayEndothelial growth factor pathwayCancer cell pathwaysStandard salvage chemotherapyFirst-line chemotherapyPhase III studyPhase III trialsCell lung cancerSignificant survival advantageEGFR gene mutationsLeast equivalent activityVEGF receptor tyrosine kinasesCancer cell proliferationGrowth factor pathwaysGrowth factor receptorSalvage 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