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 age
2007
Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA)
Massarelli E, Miller V, Leighl N, Rosen P, Albain K, Hart L, Melnyk O, Sternas L, Ackerman J, Herbst R. Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA). Journal Of Clinical Oncology 2007, 25: 7627-7627. DOI: 10.1200/jco.2007.25.18_suppl.7627.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPartial responsePerformance statusGrade 3Prior treatmentSquamous cell lung cancerEmergent adverse eventsSignificant bleeding diathesisECOG performance statusObjective response ratePhase II studyProgression-free survivalSingle-agent activityDuration of responseMulti-center trialMost common reasonsInterim futility analysisVEGF receptor inhibitorQuality of lifeBone painEvaluable ptsFebrile neutropeniaMeasurable diseaseBrain metastasesAdverse events