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
First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors
LoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.Peer-Reviewed Original ResearchNon-small cell lung cancerMetabolic partial responseAdvanced solid tumorsPartial responseStable diseaseColorectal cancerHuman studiesSolid tumorsMaximum standardized uptake valueDose-linear kineticsElevated serum lipaseSequential dose cohortsOnly grade 3Cell lung cancerReceptor 2 agonistStandardized uptake valueHuman monoclonal agonist antibodyMonoclonal agonist antibodyAnti-tumor activitySensitive tumor cellsTumor response dataSerious AEsDose cohortsProgressive diseaseUnacceptable toxicityA 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