2023
Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial
Garon E, Spira A, Goldberg S, Chaft J, Papadimitrakopoulou V, Cascone T, Antonia S, Brahmer J, Camidge D, Powderly J, Wozniak A, Felip E, Wu S, Ascierto M, Elgeioushi N, Awad M. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1–Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. Journal Of Thoracic Oncology 2023, 18: 1094-1102. PMID: 37146752, DOI: 10.1016/j.jtho.2023.04.020.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerTreatment-related adverse eventsBlinded independent central reviewIndependent central reviewRECIST v1.1Refractory patientsAdverse eventsCentral reviewRefractory non-small cell lung cancerCommon treatment-related adverse eventsSolid Tumors version 1.1Cell death protein 1End pointPhase 1b clinical trialEfficacy of durvalumabPhase 1b studyManageable safety profilePrimary end pointSecondary end pointsProgression-free survivalResponse Evaluation CriteriaMonths of treatmentDeath protein 1
2021
Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Hong D, Strickler J, Fakih M, Falchook G, Li B, Durm G, Burns T, Ramalingam S, Goldberg S, Frank R, Marrone K, Shu C, Gandara D, Soman N, Henary H, Govindan R. Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101). Journal Of Clinical Oncology 2021, 39: tps2669-tps2669. DOI: 10.1200/jco.2021.39.15_suppl.tps2669.Peer-Reviewed Original ResearchNon-small cell lung cancerCombination regimensSolid tumorsG12C mutationKRAS p.Treatment-related adverse eventsAntitumor efficacyPhase 1b studyPrior systemic therapyOpen-label studyAdvanced solid tumorsDurable clinical benefitDose-limiting toxicityKey eligibility criteriaMetastatic solid tumorsAnticancer therapyCell lung cancerOncogenic driver mutationsCombination cohortManageable toxicityDose expansionPrimary endpointSecondary endpointsTolerability profileAdverse events