2022
A phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507).
Skoulidis F, Redman M, Suga J, Al Baghdadi T, Villano J, Goldberg S, Villaruz L, Minichiello K, Gandara D, Herbst R, Kelly K. A phase II study of talazoparib plus avelumab in patients with stage IV or recurrent nonsquamous non–small cell lung cancer bearing pathogenic STK11 genomic alterations (SWOG S1900C, LUNG-MAP sub-study, NCT04173507). Journal Of Clinical Oncology 2022, 40: 9060-9060. DOI: 10.1200/jco.2022.40.16_suppl.9060.Peer-Reviewed Original ResearchObjective response ratePhase II studyCheckpoint inhibitorsII studyStage IVPrior linesGenomic alterationsSingle-arm phase II studyArm phase II studyBest objective response rateMedian progression-free survivalPARP inhibitorsAdequate organ functionCo-primary objectivesDurable disease stabilizationMost grade 3PD-L1 TPSDisease control rateImmune checkpoint inhibitorsMedian overall survivalNon-squamous NSCLCStage IV diseaseProgression-free survivalBest objective responseOptimal therapeutic approach
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
SWOG S1400F (NCT03373760): A phase II study of durvalumab plus tremelimumab for previously treated patients with acquired resistance to PD-1 checkpoint inhibitor therapy and stage IV squamous cell lung cancer (Lung-MAP Sub-study).
Leighl N, Redman M, Rizvi N, Hirsch F, Mack P, Schwartz L, Wade J, Irvin W, Reddy S, Crawford J, Bradley J, Stinchcombe T, Ramalingam S, Miao J, Minichiello K, Gandara D, Herbst R, Papadimitrakopoulou V, Kelly K. SWOG S1400F (NCT03373760): A phase II study of durvalumab plus tremelimumab for previously treated patients with acquired resistance to PD-1 checkpoint inhibitor therapy and stage IV squamous cell lung cancer (Lung-MAP Sub-study). Journal Of Clinical Oncology 2020, 38: 9623-9623. DOI: 10.1200/jco.2020.38.15_suppl.9623.Peer-Reviewed Original ResearchSquamous lung carcinomaLung carcinomaMedian PFSAdverse eventsObjective responseDisease progressionStage IV squamous cell lung cancerPD-1 checkpoint inhibitor therapySquamous cell lung cancerPD-1 checkpoint inhibitorsGood responseAdequate organ functionGrade 4 dyspneaPerformance status 0PR/SDTreatment-related deathsCheckpoint inhibitor therapyImmune-related toxicitiesPhase II studyPD-1 inhibitionBest objective responseCell lung cancerEligible patientsQ28 daysStatus 0
2019
A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G).
Owonikoko T, Redman M, Byers L, Hirsch F, Mack P, Schwartz L, Bradley J, Stinchcombe T, Leighl N, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam S, Herbst R, Papadimitrakopoulou V, Gandara D. A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G). Journal Of Clinical Oncology 2019, 37: 9022-9022. DOI: 10.1200/jco.2019.37.15_suppl.9022.Peer-Reviewed Original ResearchPrimary analysis populationSquamous cell lung cancerCell lung cancerLung cancerMedian OSMedian PFSAdverse eventsSystemic therapyStage IV squamous cell lung cancerPARP inhibitorsAdequate organ functionZubrod performance statusFrequent adverse eventsNew safety signalsPhase II studyPlatinum-sensitive diseaseSquamous lung cancerDay of registrationMedian DoREligible patientsHematologic toxicityAccrual goalII studyPerformance statusPrior linesPhase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753).
Waqar S, Redman M, Arnold S, Hirsch F, Mack P, Schwartz L, Gandara D, Stinchcombe T, Leighl N, Ramalingam S, Tanna S, Raddin R, Minichiello K, Kelly K, Bradley J, Herbst R, Papadimitrakopoulou V. Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753). Journal Of Clinical Oncology 2019, 37: 9075-9075. DOI: 10.1200/jco.2019.37.15_suppl.9075.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCohort 1Interim analysisLung squamous cell cancerAdequate organ functionDisease control rateMedian overall survivalPhase II studySquamous cell cancerDuration of responseEvaluable patientsG3 eventsImmunotherapy exposureRECIST 1.1Stable diseasePrimary endpointSecondary endpointsUnacceptable toxicityAdverse eventsII studyHepatic involvementCell cancerPositive tumorsControl rate
2011
Phase II Study of Cetuximab in Combination With Chemoradiation in Patients With Stage IIIA/B Non–Small-Cell Lung Cancer: RTOG 0324
Blumenschein GR, Paulus R, Curran WJ, Robert F, Fossella F, Werner-Wasik M, Herbst RS, Doescher PO, Choy H, Komaki R. Phase II Study of Cetuximab in Combination With Chemoradiation in Patients With Stage IIIA/B Non–Small-Cell Lung Cancer: RTOG 0324. Journal Of Clinical Oncology 2011, 29: 2312-2318. PMID: 21555682, PMCID: PMC3107747, DOI: 10.1200/jco.2010.31.7875.Peer-Reviewed Original ResearchConceptsUnresectable stage III NSCLCEpidermal growth factor receptorStage III NSCLCCombination of cetuximabCell lung cancerOverall survivalLung cancerGrade 4 hematologic toxicityRadiation Therapy Oncology GroupAdequate organ functionCycles of paclitaxelGrade 3 esophagitisGrade 5 eventsZubrod performance statusPhase II studyPrimary end pointCompletion of therapyPhase II trialDoses of paclitaxelPoor clinical outcomeGrowth factor receptorWeekly carboplatinHematologic toxicityII trialAdverse events
2009
Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514
Bahleda R, Soria J, Harbison C, Park J, Felip E, Hanna N, Laurie S, Armand J, Shepherd F, Herbst R. Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514. Journal Of Clinical Oncology 2009, 27: 8098-8098. DOI: 10.1200/jco.2009.27.15_suppl.8098.Peer-Reviewed Original ResearchBMS-690514Skin rashPD biomarkersSkin biopsiesKRAS mutationsPhase I/II studyNon-small cell lung cancer patientsReversible acute renal insufficiencyRandomized phase II trialCell lung cancer patientsEGFR T790M mutationAdequate organ functionOral selective inhibitorDisease control rateAcute renal insufficiencyPhase I portionPhase II trialLung cancer patientsT790M mutationSubsequent surgical removalAnti-tumor activityEGFR copy numberEGFR T790MECOG PSEligible patients
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