2021
Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G
Owonikoko TK, Redman MW, Byers LA, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam SS, Herbst RS, Papadimitrakopoulou V, Gandara DR. Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G. Clinical Lung Cancer 2021, 22: 187-194.e1. PMID: 33583720, PMCID: PMC8637652, DOI: 10.1016/j.cllc.2021.01.001.Peer-Reviewed Original ResearchConceptsPrimary analysis populationOverall response rateSquamous cell lung cancerDisease control rateCell lung cancerHomologous recombination repair deficiencyLung cancerOverall survivalControl rateMedian progression-free survivalHomologous recombination repair genesSingle-agent talazoparibPhase 2 studyProgression-free survivalRepair deficiencySquamous lung cancerRecombination repair genesMedian durationMedian ageAnalysis populationEligible populationResponse ratePatientsPARP inhibitorsFinding study
2020
Lung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC).
Redman M, Papadimitrakopoulou V, Minichiello K, Gandara D, Hirsch F, Mack P, Schwartz L, Vokes E, Ramalingam S, Leighl N, Bradley J, LeBlanc M, Malik S, Miller V, Sigal E, Adam S, Blanke C, Kelly K, Herbst R. Lung-MAP (SWOG S1400): Design, implementation, and lessons learned from a biomarker-driven master protocol (BDMP) for previously-treated squamous lung cancer (sqNSCLC). Journal Of Clinical Oncology 2020, 38: 9576-9576. DOI: 10.1200/jco.2020.38.15_suppl.9576.Peer-Reviewed Original ResearchBiomarker-driven studiesLung-MAPNational Clinical Trials NetworkClinical Trials NetworkSquamous lung cancerNational Cancer InstituteLung cancerTherapy questionsCancer InstituteUnmet needSuccess of PDMaster protocolsTrials NetworkPatientsBiomarker resultsSqNSCLCRegulatory approvalTherapyDurvalumabIpilimumabNivolumabTrial partsFoundationOneNSCLCS1400
2019
A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G).
Owonikoko T, Redman M, Byers L, Hirsch F, Mack P, Schwartz L, Bradley J, Stinchcombe T, Leighl N, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam S, Herbst R, Papadimitrakopoulou V, Gandara D. A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G). Journal Of Clinical Oncology 2019, 37: 9022-9022. DOI: 10.1200/jco.2019.37.15_suppl.9022.Peer-Reviewed Original ResearchPrimary analysis populationSquamous cell lung cancerCell lung cancerLung cancerMedian OSMedian PFSAdverse eventsSystemic therapyStage IV squamous cell lung cancerPARP inhibitorsAdequate organ functionZubrod performance statusFrequent adverse eventsNew safety signalsPhase II studyPlatinum-sensitive diseaseSquamous lung cancerDay of registrationMedian DoREligible patientsHematologic toxicityAccrual goalII studyPerformance statusPrior lines