2022
COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non–Small-Cell Lung Cancer
Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2022, 40: 3383-3393. PMID: 35452273, DOI: 10.1200/jco.22.00227.Peer-Reviewed Original ResearchConceptsProgression-free survivalCell lung cancerUnresectable stage IIIConcurrent chemoradiotherapyLung cancerEastern Cooperative Oncology Group performance status 0/1Stage IIITreatment-emergent adverse eventsPerformance status 0/1Objective response ratePrimary end pointPhase II studyPhase III trialsStandard of careSignificant safety signalsPFS ratesConsolidation therapyOpen labelII studyIII trialsOverall survivalAdverse eventsDurvalumabSafety signalsMonalizumab
2004
Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1
Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, Natale RB, Schiller JH, von Pawel J, Pluzanska A, Gatzemeier U, Grous J, Ochs JS, Averbuch SD, Wolf MK, Rennie P, Fandi A, Johnson DH. Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1. Journal Of Clinical Oncology 2004, 22: 777-784. PMID: 14990632, DOI: 10.1200/jco.2004.08.001.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinDeoxycytidineDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGefitinibGemcitabineHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm InvasivenessNeoplasm StagingProbabilityPrognosisQuinazolinesReference ValuesSurvival AnalysisTreatment OutcomeConceptsChemotherapy-naive patientsAdvanced NSCLCLung cancerAdvanced non-small cell lung cancerResponse rateNon-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor gefitinibEnd pointUnresectable stage IIICycles of chemotherapyEfficacy end pointPhase II trialFirst-line gemcitabineTyrosine kinase inhibitor gefitinibPhase I trialCell lung cancerUnexpected adverse eventsMedian survival timeKinase inhibitor gefitinibFurther preclinical testingDaily gefitinibFavorable tolerabilityII trialPlacebo groupAdverse events