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
2019
S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC).
Argiris A, Miao J, Cristea M, Chen A, Sands J, Decker R, Gettinger S, Daly M, Faller B, Albain K, Yanagihara R, Garland L, Byers L, Wang D, Koczywas M, Redman M, Kelly K, Gandara D. S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2019, 37: 8523-8523. DOI: 10.1200/jco.2019.37.15_suppl.8523.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerAdverse eventsG3 anemiaG3 thrombocytopeniaOverall survivalUnresectable stage III non-small cell lung cancerPARP inhibitorsG3 adverse eventsG3 oral mucositisG3-4 neutropeniaG4 adverse eventsPhase II dosePlacebo-controlled trialCell lung cancerDose-finding studyPhase I partPhase IIBackbone regimenConsolidation carboplatinEvaluable patientsG3 fatigueG3 nauseaG3 neutropenia
2013
First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results.
Camidge D, Bazhenova L, Salgia R, Weiss G, Langer C, Shaw A, Narasimhan N, Dorer D, Rivera V, Zhang J, Clackson T, Haluska F, Gettinger S. First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results. Journal Of Clinical Oncology 2013, 31: 8031-8031. DOI: 10.1200/jco.2013.31.15_suppl.8031.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdverse eventsAdvanced malignanciesCommon grade 3/4 treatment-related adverse eventsGrade 3/4 treatment-related adverse eventsEGFR-TKI resistant NSCLCNon-small cell lung cancerTreatment-related adverse eventsALK tyrosine kinase inhibitorsPhase I/IINovel tyrosine kinase inhibitorEGFR tyrosine kinase inhibitorsDose finding phaseGrade 4 dyspneaTKI-resistant NSCLCPhase II doseFollow-up scanCell lung cancerDose-finding studyAge 60 yrAnaplastic lymphoma kinaseAnti-tumor activityEpidermal growth factor receptorGrowth factor receptorStable disease