2024
Tyrosine kinase inhibitors with and without upfront CNS radiation for brain metastases in oncogene-driven non-small cell lung cancer (TURBO-NSCLC).
Miao E, Pike L, Boe L, Patil T, Myall N, Hui C, Pollom E, Qu V, Langston J, Grant M, Goldberg S, Palmer J, Prasad R, Wang T, Lee A, Shu C, Chen L, Thomas N, Camidge D, Rusthoven C. Tyrosine kinase inhibitors with and without upfront CNS radiation for brain metastases in oncogene-driven non-small cell lung cancer (TURBO-NSCLC). Journal Of Clinical Oncology 2024, 42: 2019-2019. DOI: 10.1200/jco.2024.42.16_suppl.2019.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsUpfront stereotactic radiosurgeryCentral nervous systemTKI-naive patientsStereotactic radiosurgeryOverall survivalMultivariable adjustmentCNS controlNeurological symptomsCNS objective response rateOncogene-driven non-small cell lung cancerFirst-generation TKIsKinase inhibitorsUpfront tyrosine kinase inhibitorNon-small cell lung cancerCentral nervous system radiationGeneration tyrosine kinase inhibitorsEGFR-mutant NSCLCMulti-institutional seriesObjective response rateInferior overall survivalMedian follow-upTreatment of BMCell lung cancerCox proportional hazards modelsComprehensive characterization of ERBB2 genomic alterations inlung cancer.
El Zarif T, Stockhammer P, Schillo J, Goldberg S, Politi K, Grant M. Comprehensive characterization of ERBB2 genomic alterations inlung cancer. Journal Of Clinical Oncology 2024, 42: 3148-3148. DOI: 10.1200/jco.2024.42.16_suppl.3148.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalShorter progression-free survivalTyrosine kinase domainSystemic therapyCo-mutationsClinical characteristics of non-small cell lung cancerCharacteristics of non-small cell lung cancerFirst-line platinum-based chemotherapyMedian tumor mutation burdenNon-small cell lung cancer tumorsFirst-line systemic therapyTP53 co-mutationsPlatinum-based chemotherapyTumor mutational burdenKaplan-Meier methodCell lung cancerLog-rank testOptimal treatment strategyHistory of smokingCopy number profilesTumor profile dataJuxtamembrane domainSquamous histologyTrastuzumab deruxtecan
2023
1103 Spatial mapping and clinical significance of the CD39/CD73 adenosinergic pathway as a candidate immunotherapy target in non-small cell lung cancer
Ashley K, Iyer K, Kumar R, Cooper Z, Herbst R, Goldberg S, Schalper K. 1103 Spatial mapping and clinical significance of the CD39/CD73 adenosinergic pathway as a candidate immunotherapy target in non-small cell lung cancer. 2023, a1214-a1214. DOI: 10.1136/jitc-2023-sitc2023.1103.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerAdenosinergic pathwayLung cancerImmunotherapy targetClinical significanceCancerBrief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial
Garon E, Spira A, Goldberg S, Chaft J, Papadimitrakopoulou V, Cascone T, Antonia S, Brahmer J, Camidge D, Powderly J, Wozniak A, Felip E, Wu S, Ascierto M, Elgeioushi N, Awad M. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. Journal Of Thoracic Oncology 2023, 18: 1094-1102. PMID: 37146752, DOI: 10.1016/j.jtho.2023.04.020.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerTreatment-related adverse eventsBlinded independent central reviewIndependent central reviewRECIST v1.1Refractory patientsAdverse eventsCentral reviewRefractory non-small cell lung cancerCommon treatment-related adverse eventsSolid Tumors version 1.1Cell death protein 1End pointPhase 1b clinical trialEfficacy of durvalumabPhase 1b studyManageable safety profilePrimary end pointSecondary end pointsProgression-free survivalResponse Evaluation CriteriaMonths of treatmentDeath protein 1The Evolving Role for Systemic Therapy in Resectable Non-small Cell Lung Cancer
Grant M, Woodard G, Goldberg S. The Evolving Role for Systemic Therapy in Resectable Non-small Cell Lung Cancer. Hematology/Oncology Clinics Of North America 2023, 37: 513-531. PMID: 37024389, DOI: 10.1016/j.hoc.2023.02.003.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerMetastatic non-small cell lung cancerResectable non-small cell lung cancerImmuno-oncology agentsHistologic classification systemUnited States FoodResectable tumorsSystemic therapyDriver alterationsDrug AdministrationStates FoodSystemic managementPatientsTherapyCancerEvolving roleClassification systemNTRKHER2TumorsKRASEGFRBRAFEfficacy of Osimertinib in Patients with Lung Cancer Positive for Uncommon EGFR Exon 19 Deletion Mutations
Grant M, Aredo J, Starrett J, Stockhammer P, van Rosenburgh I, Wurtz A, Piper-Valillo A, Piotrowska Z, Falcon C, Yu H, Aggarwal C, Scholes D, Patil T, Nguyen C, Phadke M, Li F, Neal J, Lemmon M, Walther Z, Politi K, Goldberg S. Efficacy of Osimertinib in Patients with Lung Cancer Positive for Uncommon EGFR Exon 19 Deletion Mutations. Clinical Cancer Research 2023, 29: of1-of8. PMID: 36913537, PMCID: PMC10493186, DOI: 10.1158/1078-0432.ccr-22-3497.Peer-Reviewed Original ResearchConceptsProgression-free survivalNon-small cell lung cancerInferior progression-free survivalMulticenter retrospective cohortEfficacy of osimertinibMulti-institutional cohortCell lung cancerExon 19 deletion mutationUncommon EGFRRetrospective cohortClinical outcomesClinical efficacyLung cancerOsimertinib efficacyEGFR mutationsPreclinical modelsEx19delPatientsAACR Genie databaseLater linesOsimertinibMutant cohortFirst lineCohortEfficacy
2022
A phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR -mutant non–small cell lung cancer (NSCLC).
Spira A, Spigel D, Camidge D, De Langen A, Kim T, Goto K, Elamin Y, Shum E, Reckamp K, Rotow J, Goldberg S, Gadgeel S, Leal T, Albayya F, Fitzpatrick S, Louie-Gao M, Parepally J, Zalutskaya A, Yu H. A phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR -mutant non–small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2022, 40: tps9142-tps9142. DOI: 10.1200/jco.2022.40.16_suppl.tps9142.Peer-Reviewed Original ResearchNon-small cell lung cancerEGFRm non-small cell lung cancerTyrosine kinase inhibitorsOverall response ratePrimary endpointEastern Cooperative Oncology Group performance status 0EGFR-mutant non-small cell lung cancerPhase 1 dose escalationPhase 2 primary endpointOral tyrosine kinase inhibitorGeneration tyrosine kinase inhibitorsResistance mutationsEGFR T790M mutationDisease control rateKey exclusion criteriaPerformance status 0Phase 1/2 studyPhase 2 doseProgression-free survivalPlatinum-based chemotherapyCell lung cancerDuration of responseCentral nervous system activityKey inclusion criteriaPK/pharmacodynamics
2021
1239P ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed phase II platform study in patients (pts) with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib
Yu H, Ambrose H, Baik C, Cho B, Cocco E, Goldberg S, Goldman J, Kraljevic S, de Langen A, Okamoto I, Piotrowska Z, Pluta M, Powar S, Aransay N, Riess J, Le X. 1239P ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed phase II platform study in patients (pts) with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib. Annals Of Oncology 2021, 32: s978-s979. DOI: 10.1016/j.annonc.2021.08.1844.Peer-Reviewed Original ResearchTrial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Hong D, Strickler J, Fakih M, Falchook G, Li B, Durm G, Burns T, Ramalingam S, Goldberg S, Frank R, Marrone K, Shu C, Gandara D, Soman N, Henary H, Govindan R. Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101). Journal Of Clinical Oncology 2021, 39: tps2669-tps2669. DOI: 10.1200/jco.2021.39.15_suppl.tps2669.Peer-Reviewed Original ResearchNon-small cell lung cancerCombination regimensSolid tumorsG12C mutationKRAS p.Treatment-related adverse eventsAntitumor efficacyPhase 1b studyPrior systemic therapyOpen-label studyAdvanced solid tumorsDurable clinical benefitDose-limiting toxicityKey eligibility criteriaMetastatic solid tumorsAnticancer therapyCell lung cancerOncogenic driver mutationsCombination cohortManageable toxicityDose expansionPrimary endpointSecondary endpointsTolerability profileAdverse eventsAdoption of consolidative durvalumab among patients with locally advanced non-small cell lung cancer.
Jairam V, Pasha S, Soulos P, Goldberg S, Yu J, Decker R, Gross C, Park H. Adoption of consolidative durvalumab among patients with locally advanced non-small cell lung cancer. Journal Of Clinical Oncology 2021, 39: e20550-e20550. DOI: 10.1200/jco.2021.39.15_suppl.e20550.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerTumor characteristicsLung cancerFDA approvalConsolidative durvalumabPatient characteristicsUnresectable stage III non-small cell lung cancerStage III non-small cell lung cancerAdvanced non-small cell lung cancerFirst-line platinum-doublet chemotherapyStudy periodFlatiron Health databasePlatinum-doublet chemotherapyGuideline-concordant carePD-L1 statusMultivariable logistic regressionCochran-Armitage testDe-identified databaseChi-square testDefinitive chemoradiationDoublet chemotherapyEligible patientsPACIFIC trialSurgery details
2020
Comparative efficacy of chemoimmunotherapy versus immunotherapy alone in the front-line treatment of advanced non-small cell lung cancer: A systematic review and network meta-analysis.
Pathak R, Lopes G, Yu H, Ji W, Aryal M, Frumento K, Wallis C, Klaassen Z, Park H, Goldberg S. Comparative efficacy of chemoimmunotherapy versus immunotherapy alone in the front-line treatment of advanced non-small cell lung cancer: A systematic review and network meta-analysis. Journal Of Clinical Oncology 2020, 38: 9552-9552. DOI: 10.1200/jco.2020.38.15_suppl.9552.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsIpi/nivoPD-1 axis inhibitorsPD-L1 1Phase 3 RCTsPD-L1 statusPD-L1Advanced non-small cell lung cancerSingle-agent immune checkpoint inhibitorsSystematic reviewCombination immune checkpoint inhibitorsNon-small cell lung cancerDual checkpoint blockadeCTLA-4 inhibitorsFront-line treatmentCell lung cancerSignificant differencesAdvanced NSCLCICI monotherapyOS benefitCheckpoint inhibitorsProspective trialCheckpoint blockadeCombination chemotherapyNSCLC patients
2019
Final Results of a Phase II Prospective Trial Evaluating the Combination of Stereotactic Body Radiotherapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)
Campbell A, Cai W, Burkhardt D, Gettinger S, Goldberg S, Amodio M, Kaech S, Krishnaswamy S, Decker R. Final Results of a Phase II Prospective Trial Evaluating the Combination of Stereotactic Body Radiotherapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC). International Journal Of Radiation Oncology • Biology • Physics 2019, 105: s36-s37. DOI: 10.1016/j.ijrobp.2019.06.453.Peer-Reviewed Original ResearchRefining the role of adjuvant chemotherapy in stage IB and IIA NSCLC.
Pathak R, Hoag J, Goldberg S, Monsalve A, Resio B, Boffa D. Refining the role of adjuvant chemotherapy in stage IB and IIA NSCLC. Journal Of Clinical Oncology 2019, 37: 8519-8519. DOI: 10.1200/jco.2019.37.15_suppl.8519.Peer-Reviewed Original ResearchNon-small cell lung cancerNational Cancer Data BaseHigh-risk featuresIIA non-small cell lung cancerAdjuvant chemotherapyStage IBGuideline recommendationsMultivariable Cox proportional hazards regressionBenefit of ACTMulti-agent adjuvant chemotherapyRole of ACSingle-agent adjuvant chemotherapyUse of ACCox proportional hazards regressionStage IB patientsCell lung cancerProportional hazards regressionImmortal time biasNon-academic centersPT2N0 patientsT2a patientsT2b patientsNSCLC patientsSurvival benefitAC patients
2018
Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma
Campbell A, Herbst R, Gettinger S, Goldberg S, Kluger H, Chiang A, Lilenbaum R, Schalper K, Sowell R, Kaech S, Decker R. Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma. International Journal Of Radiation Oncology • Biology • Physics 2018, 102: s18-s19. DOI: 10.1016/j.ijrobp.2018.06.134.Peer-Reviewed Original ResearchMORPHEUS: A phase Ib/II multi-trial platform evaluating the safety and efficacy of cancer immunotherapy (CIT)-based combinations in patients (pts) with non-small cell lung cancer (NSCLC).
Johnson M, Solomon B, Awad M, Cho B, Gainor J, Goldberg S, Keam B, Lee D, Huang C, Helms H, Barak H, Fasso M, Bleul C, Cha E, Rizvi N. MORPHEUS: A phase Ib/II multi-trial platform evaluating the safety and efficacy of cancer immunotherapy (CIT)-based combinations in patients (pts) with non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2018, 36: tps9105-tps9105. DOI: 10.1200/jco.2018.36.15_suppl.tps9105.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerCancer immunotherapyLung cancerImmunotherapyPatientsCancerDurability of brain metastasis response and overall survival in patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab.
Goldberg S, Gettinger S, Mahajan A, Herbst R, Chiang A, Lilenbaum R, Jilaveanu L, Rowen E, Gerrish H, Komlo A, Wei W, Chiang V, Kluger H. Durability of brain metastasis response and overall survival in patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab. Journal Of Clinical Oncology 2018, 36: 2009-2009. DOI: 10.1200/jco.2018.36.15_suppl.2009.Peer-Reviewed Original ResearchFinal results of a phase I prospective trial evaluating the combination of stereotactic body radiotherapy (SBRT) with concurrent pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma.
Campbell A, Herbst R, Gettinger S, Goldberg S, Kluger H, Chiang A, Lilenbaum R, Schalper K, Sowell R, Kaech S, Decker R. Final results of a phase I prospective trial evaluating the combination of stereotactic body radiotherapy (SBRT) with concurrent pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma. Journal Of Clinical Oncology 2018, 36: 9099-9099. DOI: 10.1200/jco.2018.36.15_suppl.9099.Peer-Reviewed Original Research
2017
Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC).
Henick B, Goldberg S, Narayan A, Rossi C, Rodney S, Kole A, Politi K, Gettinger S, Herbst R, Patel A. Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: e20652-e20652. DOI: 10.1200/jco.2017.35.15_suppl.e20652.Peer-Reviewed Original ResearchNon-small cell lung cancerTyrosine kinase inhibitorsEGFR-mutant non-small cell lung cancerCtDNA levelsDisease progressionRadiographic progressionTKI therapyEGFR mutationsEGFR mutation-positive non-small cell lung cancerMutation-positive non-small cell lung cancerT790MAnti-PD-1 monotherapyEGFR mutation-positive patientsPD-1 inhibitor monotherapyEGFR-mutant NSCLC patientsSubset of patientsCell lung cancerMutation-positive patientsAssessment of responseLow ctDNA levelsChart reviewClinical characteristicsDurable responsesInhibitor monotherapyNSCLC patients
2015
Tumor response from durvalumab (MEDI4736) + tremelimumab treatment in patients with advanced non-small cell lung cancer (NSCLC) is observed regardless of PD-L1 status
Rizvi N, Chaft J, Balmanoukian A, Goldberg S, Sanborn R, Steele K, Rebelatto M, Gu Y, Karakunnel J, Antonia S. Tumor response from durvalumab (MEDI4736) + tremelimumab treatment in patients with advanced non-small cell lung cancer (NSCLC) is observed regardless of PD-L1 status. Journal For ImmunoTherapy Of Cancer 2015, 3: p193. PMCID: PMC4649434, DOI: 10.1186/2051-1426-3-s2-p193.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPD-L1 statusCell lung cancerLung cancerDurvalumabPatientsCancerActivity and safety of pembrolizumab in patients with metastatic non-small cell lung cancer with untreated brain metastases.
Goldberg S, Gettinger S, Mahajan A, Herbst R, Chiang A, Tsiouris A, Vortmeyer A, Jilaveanu L, Speaker S, Madura M, Rowen E, Gerrish H, Knapp-Perry E, Yao X, Chiang V, Kluger H. Activity and safety of pembrolizumab in patients with metastatic non-small cell lung cancer with untreated brain metastases. Journal Of Clinical Oncology 2015, 33: 8035-8035. DOI: 10.1200/jco.2015.33.15_suppl.8035.Peer-Reviewed Original Research