2024
Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
John T, Grohe C, Goldman J, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn M, Perol M, Hartmaier R, Robichaux J, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Herbst R, Tsuboi M, Wu Y. Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2024, 42: 8005-8005. DOI: 10.1200/jco.2024.42.16_suppl.8005.Peer-Reviewed Original ResearchDisease-free survivalMolecular residual diseaseNon-small cell lung cancerDisease-free survival eventsDisease recurrenceEGFR-mutantOverall survivalStage IB-IIIA non-small cell lung cancerEGFR T790M resistance mutationT790M resistance mutationMedian follow-up timeEGFR-TKI sensitivityResected tumor tissueCell lung cancerTumor-specific variantsMedian lead timeWhole-exome sequencingDetection of ctDNAADAURA studyADAURA trialInvestigator-assessedMolecular recurrenceEGFR-TKIsResidual diseaseEligible pts
2023
ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC).
Padda S, Redman M, Gerber D, Stinchcombe T, Waqar S, Leal T, Minichiello K, Reckamp K, Herbst R, Borghaei H, Brahmer J, Gray J, Kelly K, Ramalingam S, Neal J. ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: tps9143-tps9143. DOI: 10.1200/jco.2023.41.16_suppl.tps9143.Peer-Reviewed Original ResearchNon-squamous non-small cell lung cancerTarget sample sizeKRAS G12C inhibitorsCohort 1Eligible ptsBrain metastasesG12C inhibitorsPhase 2 open-label studyNon-small cell lung cancerAsymptomatic brain metastasesOpen-label studyPhase II studyUntreated brain metastasesCell lung cancerDuration of responsePresence of TP53Wild-type TP53Oral dailySecondary endpointsII studySystemic treatmentAccrual targetLung cancerCohort 2Clinical activity
2021
A phase II study of rucaparib in patients with high genomic LOH and/or BRCA 1/2 mutated stage IV non-small cell lung cancer (Lung-MAP Sub-Study, S1900A).
Riess J, Redman M, Wheatley-Price P, Faller B, Villaruz L, Corum L, Gowda A, Srkalovic G, Osarogiagbon R, Baumgart M, Qian L, Minichiello K, Gandara D, Herbst R, Kelly K. A phase II study of rucaparib in patients with high genomic LOH and/or BRCA 1/2 mutated stage IV non-small cell lung cancer (Lung-MAP Sub-Study, S1900A). Journal Of Clinical Oncology 2021, 39: 9024-9024. DOI: 10.1200/jco.2021.39.15_suppl.9024.Peer-Reviewed Original ResearchHomologous recombination deficiencyBRCA1/2 mutationsPARP inhibitorsAdverse eventsSystemic therapyStage IV non-small cell lung cancerNon-small cell lung cancerAdequate organ functionFrequent adverse eventsZubrod performance statusAdvanced NSCLC patientsNew safety signalsPhase II studyStage IV diseaseAdvanced-stage NSCLCCell lung cancerPhenotypic markersBRCA1/BRCA2Day of registrationEligible patientsEligible ptsMedian OSMedian PFSNSCLC ptsHematologic toxicity
2020
Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.
Herbst R, Tsuboi M, John T, Grohé C, Majem M, Goldman J, Kim S, Marmol D, Rukazenkov Y, Wu Y. Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. Journal Of Clinical Oncology 2020, 38: lba5-lba5. DOI: 10.1200/jco.2020.38.18_suppl.lba5.Peer-Reviewed Original ResearchDisease-free survivalComplete tumor resectionDFS hazard ratioAdjuvant chemotherapyData cutoffHazard ratioOverall survivalTumor resectionAdjuvant osimertinibDFS ratesEGFRm NSCLCEGFR-TKISafety profileEGFR mutation-positive NSCLCEffective new treatment strategyResected stage IISafety of osimertinibEarly-stage diseaseMutation-positive NSCLCNew treatment strategiesUnplanned interim analysisEligible ptsIIIA NSCLCNSCLC presentPS 0/1
2017
A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B.
Wade J, Langer C, Redman M, Aggarwal C, Bradley J, Crawford J, Miao J, Griffin K, Herbst R, Kelly K, Gandara D, Papadimitrakopoulou V. A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B. Journal Of Clinical Oncology 2017, 35: 9054-9054. DOI: 10.1200/jco.2017.35.15_suppl.9054.Peer-Reviewed Original ResearchPrimary endpointInterim analysisStage IV squamous cell lung cancerResponse rateSquamous cell lung cancerNational Clinical Trials NetworkSingle-arm phase II trialArm phase II trialGrade 3 AEsGrade 5 eventsPIK3CA-mutant tumorsPrimary analysis populationPhase II studyPhase II trialOverall survival dataCell lung cancerPlatinum-based therapyPrimary platinum-based therapyClinical Trials NetworkClinical trial informationPI3K mutationsPI3K pathwayEligible ptsMedian PFSStable diseasePhase 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 endpointA multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.
Petrylak D, Arkenau H, Perez-Gracia J, Krebs M, Santana-Davila R, Yang J, Rege J, Mi G, Ferry D, Herbst R. A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma. Journal Of Clinical Oncology 2017, 35: 349-349. DOI: 10.1200/jco.2017.35.6_suppl.349.Peer-Reviewed Original ResearchTreatment-related AEsECOG PS 0Median durationPS 0PD-L1Urothelial carcinomaDay 1Phase 1a/b trialPlatinum-based systemic therapyTreatment-related grade 4Advanced urothelial carcinomaElevated alanine aminotransferaseNew safety signalsElevated aspartate aminotransferaseBaseline tumor tissuePreliminary efficacy dataTransitional cell carcinomaEligible ptsMeasurable diseaseMedian PFSStable diseasePartial responseProgressive diseaseSystemic therapyMedian age
2009
Phase II pilot study of neoadjuvant docetaxel and cisplatin followed by adjuvant erlotinib in patients with stage I-III non-small cell lung cancer (NSCLC)
Gold K, Lee J, Rice D, Tse W, Stewart D, Wistuba I, Herbst R, Lippman S, Hong W, Kim E. Phase II pilot study of neoadjuvant docetaxel and cisplatin followed by adjuvant erlotinib in patients with stage I-III non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2009, 27: 7566-7566. DOI: 10.1200/jco.2009.27.15_suppl.7566.Peer-Reviewed Original ResearchNon-small cell lung cancerStage ISurgical resectionResectable non-small cell lung cancerEarly-stage non-small cell lung cancerStage non-small cell lung cancerResponse rateECOG performance status 0Phase II pilot studyAdequate laboratory parametersCurative-intent therapyCycles of chemotherapyDefinitive surgical resectionGrade 3/4 toxicitiesPerformance status 0Radiographic response rateBenefit of chemotherapyComplete pathologic responseEncouraging response ratesCell lung cancerYr of treatmentActive regimenAdjuvant erlotinibCancer ptsEligible ptsS0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study
Gandara D, Kim E, Herbst R, Moon J, Redman M, Dakhil S, Hirsch F, Mack P, Franklin W, Kelly K. S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study. Journal Of Clinical Oncology 2009, 27: 8015-8015. DOI: 10.1200/jco.2009.27.15_suppl.8015.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalOverall survivalEGFR FISHStable diseasePartial responseNon-squamous cell non-small cell lung cancerDay 1Median age 64 yearsTreatment-related deathsDisease control ratePhase II studyPhase III trialsPlatinum-based chemotherapyAge 64 yearsCell lung cancerEfficacy of carboplatinActive regimenAUC 6Bevacizumab maintenanceEligible ptsMedian followBrain metastasesEfficacy outcomesPhase 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
A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): Final report of SWOG 0342
Herbst R, Chansky K, Kelly K, Atkins J, Davies A, Dakhil S, Albain K, Kim E, Crowley J, Gandara D. A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): Final report of SWOG 0342. Journal Of Clinical Oncology 2007, 25: 7545-7545. DOI: 10.1200/jco.2007.25.18_suppl.7545.Peer-Reviewed Original ResearchNon-small cell lung cancerSmall-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitorAdvanced non-small cell lung cancerAdvanced stage non-small cell lung cancerMetastatic non-small cell lung cancerStage non-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsReceptor tyrosine kinase inhibitorsAdequate organ functionPhase III settingSuperior median survivalPhase II trialPhase III trialsCell lung cancerRandomized clinical trialsMolecular correlative studiesTyrosine kinase inhibitorsAnti-tumor activityPhase II selection trialTrue hazard ratioConcurrent chemotherapyConcurrent regimenEligible patientsEligible pts
2006
Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): A randomized phase II selectional trial SWOG 0342
Kelly K, Herbst R, Crowley J, McCoy J, Atkins J, Lara P, Dakhil S, Albain K, Kim E, Gandara D. Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): A randomized phase II selectional trial SWOG 0342. Journal Of Clinical Oncology 2006, 24: 7015-7015. DOI: 10.1200/jco.2006.24.18_suppl.7015.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase II trialII trialLarge randomized phase II trialRandomized phase II trialSmall-molecule EGFR tyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsAdequate organ functionPhase III settingPhase III trialsYears of therapyCell lung cancerRandomized clinical trialsMolecular correlative studiesTyrosine kinase inhibitorsAnti-tumor activityTrue hazard ratioConcurrent chemotherapyConcurrent regimenEligible ptsPrimary endpointStage IIIBUntreated patientsHazard ratio