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
2020
A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)
Waqar SN, Redman MW, Arnold SM, Hirsch FR, Mack PC, Schwartz LH, Gandara DR, Stinchcombe TE, Leighl NB, Ramalingam SS, Tanna SH, Raddin RS, Minichiello K, Bradley JD, Kelly K, Herbst RS, Papadimitrakopoulou VA. A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Clinical Lung Cancer 2020, 22: 170-177. PMID: 33221175, PMCID: PMC8044254, DOI: 10.1016/j.cllc.2020.09.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPneumoniaProgression-Free SurvivalProto-Oncogene Proteins c-metSurvival RateTreatment OutcomeConceptsSquamous cell carcinomaProgression-free survivalTelisotuzumab vedotinCohort 1Recurrent squamous cell lung cancerSquamous cell lung cancerGrade 5 eventsMET-positive tumorsSolid Tumors v1.1Disease control ratePhase II studyResponse Evaluation CriteriaCell lung cancerDuration of responseLack of efficacyEvaluable patientsStable diseasePrimary endpointSecondary endpointsUnacceptable toxicityII studyOverall survivalCell carcinomaControl rateLung cancerPembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation Criteria
2019
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).
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
2006
Apo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma
Ling J, Herbst R, Mendelson D, Eckhardt S, O’Dwyer P, Ebbinghaus S, Osborne R, Cheu M, Lieberman G, Lum B. Apo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma. Journal Of Clinical Oncology 2006, 24: 3047-3047. DOI: 10.1200/jco.2006.24.18_suppl.3047.Peer-Reviewed Original ResearchApo2L/TRAILCohort 1PK dataSerum concentrationsCohort 2Preclinical modelsRecombinant human Apo2L/TRAILPhase 1a studyPhase 1a trialMild liver dysfunctionNon-compartmental analysisTumor xenograft modelSensitive ELISA assayLiver dysfunctionLiver metastasesPK assessmentAdvanced cancerHepatic metastasesIV infusionNonclinical modelsHematologic cancersXenograft modelClinical developmentDay 1Dose levels