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
2019
SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
Langer CJ, Redman MW, Wade JL, Aggarwal C, Bradley JD, Crawford J, Stella PJ, Knapp MH, Miao J, Minichiello K, Herbst RS, Kelly K, Gandara DR, Papadimitrakopoulou VA. SWOG S1400B (NCT02785913), a Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study). Journal Of Thoracic Oncology 2019, 14: 1839-1846. PMID: 31158500, PMCID: PMC7017958, DOI: 10.1016/j.jtho.2019.05.029.Peer-Reviewed Original ResearchConceptsPrimary analysis populationProgression-free survivalPrimary endpointOverall survivalStage IV squamous cell lung cancerGrade 3 adverse eventsMedian progression-free survivalSolid Tumors version 1.1Squamous cell lung cancerTreatment-related deathsPhase II studyResponse Evaluation CriteriaSubset of patientsCell lung cancerDuration of responsePlatinum-based therapyInterim futility analysisPI3K inhibitorsEligible patientsEvaluable populationSquamous NSCLCSecondary endpointsAdverse eventsII studyMedian ageA 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
2017
A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B.
Wade J, Langer C, Redman M, Aggarwal C, Bradley J, Crawford J, Miao J, Griffin K, Herbst R, Kelly K, Gandara D, Papadimitrakopoulou V. A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B. Journal Of Clinical Oncology 2017, 35: 9054-9054. DOI: 10.1200/jco.2017.35.15_suppl.9054.Peer-Reviewed Original ResearchPrimary endpointInterim analysisStage IV squamous cell lung cancerResponse rateSquamous cell lung cancerNational Clinical Trials NetworkSingle-arm phase II trialArm phase II trialGrade 3 AEsGrade 5 eventsPIK3CA-mutant tumorsPrimary analysis populationPhase II studyPhase II trialOverall survival dataCell lung cancerPlatinum-based therapyPrimary platinum-based therapyClinical Trials NetworkClinical trial informationPI3K mutationsPI3K pathwayEligible ptsMedian PFSStable disease