2024
SWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.
Reckamp K, Redman M, Dragnev K, Iams W, Henick B, Miao J, LeBlanc M, Carrizosa D, Herbst R, Blanke C, Gray J. SWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. Journal Of Clinical Oncology 2024, 42: tps8657-tps8657. DOI: 10.1200/jco.2024.42.16_suppl.tps8657.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerStandard of careCell lung cancerPD-(L)1Overall survivalAdverse eventsRecurrent non-small cell lung cancerLung cancerTreatment-related adverse eventsRandomized phase II trialStandard of care treatmentPlatinum-based therapyTreated with immunotherapyPhase II trialLog-rank testCompare OSInhibitor therapyII trialCombination therapyStatistically significant improvementTumor resistanceSafety profileTherapeutic optionsRandomized study
2019
SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
Langer CJ, Redman MW, Wade JL, Aggarwal C, Bradley JD, Crawford J, Stella PJ, Knapp MH, Miao J, Minichiello K, Herbst RS, Kelly K, Gandara DR, Papadimitrakopoulou VA. SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study). Journal Of Thoracic Oncology 2019, 14: 1839-1846. PMID: 31158500, PMCID: PMC7017958, DOI: 10.1016/j.jtho.2019.05.029.Peer-Reviewed Original ResearchConceptsPrimary analysis populationProgression-free survivalPrimary endpointOverall survivalStage IV squamous cell lung cancerGrade 3 adverse eventsMedian progression-free survivalSolid Tumors version 1.1Squamous cell lung cancerTreatment-related deathsPhase II studyResponse Evaluation CriteriaSubset of patientsCell lung cancerDuration of responsePlatinum-based therapyInterim futility analysisPI3K inhibitorsEligible patientsEvaluable populationSquamous NSCLCSecondary endpointsAdverse eventsII studyMedian age
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
2008
Overview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies
Vermorken JB, Herbst RS, Leon X, Amellal N, Baselga J. Overview of the efficacy of cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck in patients who previously failed platinum‐based therapies. Cancer 2008, 112: 2710-2719. PMID: 18481809, DOI: 10.1002/cncr.23442.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Squamous CellCetuximabCisplatinClinical Trials as TopicDrug Resistance, NeoplasmHead and Neck NeoplasmsHumansMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRetrospective StudiesSurvival AnalysisTreatment OutcomeConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaMetastatic SCCHNPlatinum therapyRetrospective studyCell carcinomaEpidermal growth factor receptor (EGFR) inhibitor cetuximabActivity of cetuximabCarboplatin-based chemotherapyCetuximab-based treatmentCisplatin/carboplatinDisease control rateMedian overall survivalSecond-line therapySecond-line treatmentEfficacy of cetuximabPlatinum-based therapyOverall response ratePlatinum failureOverall survivalMedian timeProlong survivalProspective studyControl rateEfficacy data
2005
Phase II Multicenter Study of the Epidermal Growth Factor Receptor Antibody Cetuximab and Cisplatin for Recurrent and Refractory Squamous Cell Carcinoma of the Head and Neck
Herbst RS, Arquette M, Shin DM, Dicke K, Vokes EE, Azarnia N, Hong WK, Kies MS. Phase II Multicenter Study of the Epidermal Growth Factor Receptor Antibody Cetuximab and Cisplatin for Recurrent and Refractory Squamous Cell Carcinoma of the Head and Neck. Journal Of Clinical Oncology 2005, 23: 5578-5587. PMID: 16009949, DOI: 10.1200/jco.2005.07.120.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionDrug Administration ScheduleFemaleFluorouracilHead and Neck NeoplasmsHumansLogistic ModelsMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelSurvival AnalysisTreatment OutcomeConceptsSquamous cell carcinomaSkin rashCell carcinomaAcne-like skin rashMulticenter phase II studyPhase II multicenter studyRefractory squamous cell carcinomaMedian overall survival timeEpidermal growth factor receptor antibody cetuximabRecurrent squamous cell carcinomaCisplatin/fluorouracilCisplatin/paclitaxelSafety of cetuximabPhase II studyMajority of patientsOverall survival timePlatinum-based therapySingle-agent trialsSerious allergic reactionsMurine monoclonal antibodiesActive regimenStable diseaseCommon toxicitiesII studyMedian duration
2002
Angiogenesis inhibitors in clinical development for lung cancer
Herbst RS, Hidalgo M, Pierson AS, Holden SN, Bergen M, Eckhardt SG. Angiogenesis inhibitors in clinical development for lung cancer. Seminars In Oncology 2002, 29: 66-77. PMID: 11894016, DOI: 10.1053/sonc.2002.31527.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials as TopicDisease ProgressionEndothelial Growth FactorsEndpoint DeterminationEnzyme InhibitorsHumansLung NeoplasmsLymphokinesMatrix Metalloproteinase InhibitorsMatrix MetalloproteinasesNeovascularization, PathologicTreatment OutcomeVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsAngiogenesis inhibitorsLung cancerClinical trialsClinical developmentPhase II trialLong-term administrationPlatinum-based therapyEarly clinical trialsReceptor-targeted agentsPrimary endpointAdvanced diseaseII trialMetastatic diseaseAdjunctive therapyProcess of angiogenesisCancer patientsField of angiogenesisEfficacious dosesClinical evaluationTumor regressionNovel agentsAntiangiogenic agentsTherapeutic targetDependence of tumorsTumor angiogenesis