2024
Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm A
2013
Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
Topalian S, Sznol M, Brahmer J, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Powderly J, Carvajal R, Sosman J, Atkins M, Antonia S, Spigel D, Lawrence D, Kollia G, Gupta A, Wigginton J, Hodi F. Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. Journal Of Clinical Oncology 2013, 31: 3002-3002. DOI: 10.1200/jco.2013.31.15_suppl.3002.Peer-Reviewed Original ResearchAdvanced solid tumorsLong-term safetySolid tumorsNon-small cell lung cancerLong-term safety profileDrug-related AEsDrug-related pneumonitisCo-inhibitory receptorsPhase III trialsPhase I trialCell lung cancerOngoing clinical developmentActivated T cellsCohort expansionMedian OSRECIST 1.0Efficacy outcomesUnacceptable toxicityIII trialsDeath-1Dose escalationI trialPD-1G3/G4Safety profileSurvival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Sankar V, Ahlers C, Wigginton J, Kollia G, Gupta A, Gettinger S. Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8030-8030. DOI: 10.1200/jco.2013.31.15_suppl.8030.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase I trialOverall survivalMedian OSI trialCommon drug-related AEsDrug-related AEsMedian overall survivalPrior chemotherapy regimenAcceptable safety profilePhase 1 studyCell lung cancerPD-1 receptorImmune checkpoint receptorsDrug-related deathsT cell activationNSCLC ptsOS benefitChemotherapy regimenDose cohortsCheckpoint receptorsDeath-1Safety profileDiscontinuation criteria
2012
A randomized discontinuation phase II trial of ridaforolimus in non-small cell lung cancer (NSCLC) patients with KRAS mutations.
Riely G, Brahmer J, Planchard D, Crinò L, Doebele R, Mas Lopez L, Gettinger S, Schumann C, Li X, Atkins B, Ebbinghaus S, Rosell R. A randomized discontinuation phase II trial of ridaforolimus in non-small cell lung cancer (NSCLC) patients with KRAS mutations. Journal Of Clinical Oncology 2012, 30: 7531-7531. DOI: 10.1200/jco.2012.30.15_suppl.7531.Peer-Reviewed Original ResearchProgression-free survivalStable diseaseKRAS mutationsAdvanced NSCLCStage IIIB/IV non-small cell lung cancerResponse rateNon-small cell lung cancer patientsNon-small cell lung cancerMedian progression-free survivalProlonged progression-free survivalCell lung cancer patientsAvailable standard treatmentMucositis/stomatitisPhase II trialAdvanced endometrial cancerCell lung cancerLung cancer patientsOverall response rateSoft tissue sarcomasDays/week scheduleKRAS-mutant NSCLCInhibitor of mTORMedian OSOral ridaforolimusPrior chemotherapy