2021
457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC)
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. 457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC). Journal For ImmunoTherapy Of Cancer 2021, 9: a485-a485. DOI: 10.1136/jitc-2021-sitc2021.457.Peer-Reviewed Original ResearchTreatment-related adverse eventsNon-small cell lung cancerAdvanced non-small cell lung cancerCombination therapyInterim analysisBiomarker subgroupsMost treatment-related adverse eventsT-cell-inflamed gene expression profileHigh subgroupBiomarker-defined subgroupsPrimary end pointPhase 2 studyPhase 2 trialFirst-line pembrolizumabCell lung cancerFirst interim analysisSubsidiary of MerckInstitutional review boardRECIST v1.1Data cutoffAdverse eventsDohme Corp.Lung cancerMature dataStudy protocol
2020
Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403.
Goldberg SB, Redman MW, Lilenbaum R, Politi K, Stinchcombe TE, Horn L, Chen EH, Mashru SH, Gettinger SN, Melnick MA, Herbst RS, Baumgart MA, Miao J, Moon J, Kelly K, Gandara DR. Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403. Journal Of Clinical Oncology 2020, 38: 4076-4085. PMID: 33021871, PMCID: PMC7768342, DOI: 10.1200/jco.20.01149.Peer-Reviewed Original ResearchConceptsProgression-free survivalLung cancerMutant NSCLCEGFR monoclonal antibody cetuximabSmall cell lung cancerAddition of cetuximabPrimary end pointTyrosine kinase inhibitor afatinibCell lung cancerEGFR-Mutant NonCombination of afatinibMonoclonal antibody cetuximabAdvanced diseaseAdverse eventsOverall survivalMulticenter trialLine treatmentEGFR-TKIAntibody cetuximabDose reductionInhibitor afatinibInterim analysisCetuximabInsufficient evidencePatients
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 rateA phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952).
Bazhenova L, Redman M, Gettinger S, Hirsch F, Mack P, Schwartz L, Gandara D, Bradley J, Stinchcombe T, Leighl N, Ramalingam S, Tavernier S, Minichiello K, Kelly K, Papadimitrakopoulou V, Herbst R. A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952). Journal Of Clinical Oncology 2019, 37: 9014-9014. DOI: 10.1200/jco.2019.37.15_suppl.9014.Peer-Reviewed Original ResearchInvestigator-assessed progression-free survivalOverall survivalInterim analysisStage IV squamous cell lung cancerSquamous cell lung cancerGrade 5 AEsImmunotherapy-naïve patientsStudies of nivolumabTreatment-related AEsPD-L1 expressionProgression-free survivalPhase IIICell lung cancerECOG 0Primary endpointRECIST 1.1Baseline characteristicsPD-L1Lung cancerLung-MAPNivolumabStage IVPatientsResponse rateMaster protocols
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 disease
2003
O-311 A phase III study of Æ-941 (Neovastat®) with induction chemotherapy (IC) and conconmitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): An interim analysis of toxicity and response
Lu C, Komaki R, Herbst R, Evans W, Smith T, Moore C, Kolbye S, Choi N, Choy H, Bleyer A. O-311 A phase III study of Æ-941 (Neovastat®) with induction chemotherapy (IC) and conconmitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): An interim analysis of toxicity and response. Lung Cancer 2003, 41: s90. DOI: 10.1016/s0169-5002(03)91969-6.Peer-Reviewed Original Research