2022
Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials
Gettinger SN, Huber RM, Kim DW, Bazhenova L, Hansen KH, Tiseo M, Langer CJ, Rodríguez L, West HL, Reckamp KL, Weiss GJ, Smit EF, Hochmair MJ, Kim SW, Ahn MJ, Kim ES, Groen HJM, Pye J, Liu Y, Zhang P, Vranceanu F, Camidge DR. Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. JTO Clinical And Research Reports 2022, 3: 100385. PMID: 36065449, PMCID: PMC9440305, DOI: 10.1016/j.jtocrr.2022.100385.Peer-Reviewed Original ResearchProgression-free survivalPhase 1/2 studyMedian investigator-assessed progression-free survivalInvestigator-assessed progression-free survivalMedian overall survivalPhase 2 trialLong-term efficacyOverall survivalPhase 1/2Arm AStudy endMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialNew safety signalsIndependent review committeeArm B.Advanced malignanciesBrain metastasesManageable safetyArm BPositive NSCLCSafety signalsNSCLCPatients
2013
A phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts).
Rizvi N, Antonia S, Chow L, Brahmer J, Juergens R, Borghaei H, Shepherd F, Laurie S, Gerber D, Goldman J, Shen Y, Harbison C, Alaparthy S, Chen A, Gettinger S. A phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts). Journal Of Clinical Oncology 2013, 31: 8072-8072. DOI: 10.1200/jco.2013.31.15_suppl.8072.Peer-Reviewed Original ResearchNSCLC ptsArm APhase INon-small cell lung cancer patientsPlatinum-based doublet chemotherapyCell lung cancer patientsCarboplatin/paclitaxelIncidence of DLTTolerable safety profileGemcitabine/cisplatinLung cancer patientsDe-escalation designWk of dosingGr 3Doublet chemotherapyNivolumab dosesStandard dosingAspergillus pneumoniaChemotherapy regimenDose cohortsDurable responsesArm BMaintenance treatmentConfirmation of responseSafety profile