2021
A Dose-finding Study Followed by a Phase II Randomized, Placebo-controlled Trial of Chemoradiotherapy With or Without Veliparib in Stage III Non–small-cell Lung Cancer: SWOG 1206 (8811)
Argiris A, Miao J, Cristea MC, Chen AM, Sands JM, Decker RH, Gettinger SN, Daly ME, Faller BA, Albain KS, Yanagihara RH, Garland LL, Byers LA, Wang D, Koczywas M, Redman MW, Kelly K, Gandara DR. A Dose-finding Study Followed by a Phase II Randomized, Placebo-controlled Trial of Chemoradiotherapy With or Without Veliparib in Stage III Non–small-cell Lung Cancer: SWOG 1206 (8811). Clinical Lung Cancer 2021, 22: 313-323.e1. PMID: 33745865, PMCID: PMC8562492, DOI: 10.1016/j.cllc.2021.02.009.Peer-Reviewed Original ResearchConceptsProgression-free survivalDose-limiting toxicityGrade 3 esophagitisPhase II partCell lung cancerLung cancerStage IIIPARP inhibitorsConcurrent weekly carboplatinEarly study closurePhase II RandomizedTrial of chemoradiotherapyDose-finding studyPhase I partStandard of careAdjuvant immunotherapyConsolidation carboplatinEligible patientsVeliparib doseWeekly carboplatinThoracic radiotherapyOverall survivalPlacebo armStudy closurePredictive biomarkers
2020
Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling
Zugazagoitia J, Gupta S, Liu Y, Fuhrman K, Gettinger S, Herbst RS, Schalper KA, Rimm DL. Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling. Clinical Cancer Research 2020, 26: 4360-4368. PMID: 32253229, PMCID: PMC7442721, DOI: 10.1158/1078-0432.ccr-20-0175.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPD-1 checkpoint blockadeCell lung cancerCheckpoint blockadeLung cancerAdvanced non-small cell lung cancerUnivariate unadjusted analysisProgression-free survivalImmune cell countsMinority of patientsRobust predictive biomarkersBiomarkers of responseLarge independent cohortsSpatial profiling technologyDigital spatial profilingDigital spatial profiling (DSP) technologyOverall survivalClinical outcomesImmune predictorsHigher CD56NSCLC casesPredictive biomarkersUnadjusted analysesImmune parametersTissue microarray
2015
Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study.
Horn L, Spigel D, Gettinger S, Antonia S, Gordon M, Herbst R, Sequist L, Chappey C, Kowanetz M, Sandler A, Soria J. Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study. Journal Of Clinical Oncology 2015, 33: 8029-8029. DOI: 10.1200/jco.2015.33.15_suppl.8029.Peer-Reviewed Original Research
2013
BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC).
Papadimitrakopoulou V, Wistuba I, Lee J, Tsao A, Kalhor N, Fossella F, Heymach J, Alden C, Gettinger S, Coombes K, Saintigny P, Tang X, Duffield E, Boyer J, Davis S, Powis G, Mauro D, Rubin E, Hong W, Herbst R. BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8118-tps8118. DOI: 10.1200/jco.2013.31.15_suppl.tps8118.Peer-Reviewed Original ResearchNon-small cell lung cancerDisease control rateEvaluable ptsKRAS statusPredictive biomarkersRefractory non-small cell lung cancerAdvanced non-small cell lung cancerEML4/ALK translocationsPhase II clinical trialStage 1Lung Cancer EliminationOptimal patient selectionCell lung cancerEffective therapeutic strategyMEK inhibitor selumetinibUnmet medical needBiomarkers of resistanceAKT inhibitor MKPersonalized medicine approachPI3K/AktStage 2NCSLC patientsNSCLC ptsPatient selectionNSCLC treatment
2012
Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response.
Topalian S, Brahmer J, Hodi F, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Antonia S, Spigel D, Atkins M, Lawrence D, McDonald D, Jure-Kunkel M, Korman A, Kollia G, Gupta A, Wigginton J, Sznol M. Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response. Journal Of Clinical Oncology 2012, 30: cra2509-cra2509. DOI: 10.1200/jco.2012.30.18_suppl.cra2509.Peer-Reviewed Original ResearchPD-1/PD-L1 pathwayPD-L1 pathwayPotential predictive biomarkersBMS-936558Predictive biomarkersNon-small cell lung cancerPre-treatment tumor biopsiesCastrate-resistant prostate cancerCo-inhibitory receptorsPD-L1 expressionPD-1 ligandsCell lung cancerOverall tumor burdenActivated T cellsCohort expansionEvaluable ptsRECIST 1.0Advanced NSCLCMedian durationDeath-1PD-1PD-L1Therapy cyclesNew lesionsTumor burden