2025
PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.
Dragnev K, Redman M, Reckamp K, Khalil M, Henick B, Moon J, Ahmadzai P, LeBlanc M, Carrizosa D, Hesketh P, Sigal E, Allen J, Saltos A, Faller B, Herbst R, Blanke C, Gray J. PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. Journal Of Clinical Oncology 2025, 43: lba8671-lba8671. DOI: 10.1200/jco.2025.43.17_suppl.lba8671.Peer-Reviewed Original ResearchSquamous cell carcinomaOverall survivalAdvanced NSCLCRecurrent non-small cell lung cancerRandomized phase III trialMedian of follow-upNon-small cell lung cancerPhase II Randomized StudyInterim analysisTreated with ICIPlatinum-based therapyTreated with immunotherapyPhase III trialsCell lung cancerLong follow-upStandard of careChemotherapy-freeHistological subgroupsNon-SCCIII trialsCell carcinomaMedian ageToxicity profileRandomized studyAdverse eventsSWOG S2302, PRAGMATICA-LUNG: A pragmatic trial designed to increase participant representation.
Reckamp K, Redman M, Dragnev K, Khalil M, Henick B, Moon J, Ahmadzai P, LeBlanc M, Carrizosa D, Herbst R, Blanke C, Gray J. SWOG S2302, PRAGMATICA-LUNG: A pragmatic trial designed to increase participant representation. Journal Of Clinical Oncology 2025, 43: 11016-11016. DOI: 10.1200/jco.2025.43.16_suppl.11016.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerStandard of careOverall survivalPD-(L)1Randomized phase III trialPhase II Randomized StudyPlatinum-based therapyTreated with immunotherapyPhase III trialsCell lung cancerYears of ageInhibitor therapyIII trialsStudy drugConcomitant medicationsOS endpointSafety profileToxicity profileAdverse eventsEffective therapyLung cancerBlack patientsReal-world practiceLaboratory assessment
2022
Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non–Small-Cell Lung Cancer Previously Treated With Immunotherapy—Lung-MAP S1800A
Reckamp KL, Redman MW, Dragnev KH, Minichiello K, Villaruz LC, Faller B, Al Baghdadi T, Hines S, Everhart L, Highleyman L, Papadimitrakopoulou V, Neal J, Waqar SN, Patel JD, Gray JE, Gandara DR, Kelly K, Herbst RS. Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non–Small-Cell Lung Cancer Previously Treated With Immunotherapy—Lung-MAP S1800A. Journal Of Clinical Oncology 2022, 40: 2295-2306. PMID: 35658002, PMCID: PMC9287284, DOI: 10.1200/jco.22.00912.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitionInvestigator-assessed progression-free survivalProgression-free survivalOverall survivalVascular endothelial growth factorLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerPhase II Randomized StudyTreatment-related adverse eventsRandomized phase II trialSecondary end pointsPhase II trialPlatinum-based chemotherapyCell lung cancerDuration of responseLog-rank testMajor unmet needEndothelial growth factorMultiple tumor typesAdvanced NSCLCEligible patientsOS benefitII trialObjective response
2019
A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB)
Mayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estévez LG, van Dam PA, Kümmel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clinical Cancer Research 2019, 25: 2975-2987. PMID: 30723140, PMCID: PMC6522303, DOI: 10.1158/1078-0432.ccr-18-3160.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCell ProliferationClass I Phosphatidylinositol 3-KinasesFemaleHigh-Throughput Nucleotide SequencingHumansLetrozoleMiddle AgedMutationNeoadjuvant TherapyReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSignal TransductionThiazolesTreatment OutcomeConceptsObjective response rateMetastatic breast cancerBreast cancerResponse rateLetrozole treatmentPathologic complete response ratePhase II Randomized StudyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorComplete response rateHormone receptor positiveMaculo-papular rashProgression-free survivalGrowth factor receptor 2Early breast cancerPhase I studiesWild-type cohortsFactor receptor 2Epidermal growth factor receptorCombination of alpelisibGrowth factor receptorNeoadjuvant letrozoleNeoadjuvant settingPrimary endpoint
2011
OT3-02-04: TBCRC 012: ABCDE, a Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Preoperative Chemotherapy for Breast Cancer.
Mayer E, Ligibel J, Burstein H, Peppercorn J, Miller K, Carey L, Dickler M, Mayer I, Forero A, Eng-Wong J, Pletcher P, Ryabin N, Gelman R, Wolff A, Winer E. OT3-02-04: TBCRC 012: ABCDE, a Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise after Preoperative Chemotherapy for Breast Cancer. Cancer Research 2011, 71: ot3-02-04-ot3-02-04. DOI: 10.1158/0008-5472.sabcs11-ot3-02-04.Peer-Reviewed Original ResearchPreoperative chemotherapyBreast cancerLifestyle interventionPhase II Randomized StudyAcceptable organ functionResidual invasive diseaseAdjuvant combination chemotherapyTaxane-based chemotherapyRecurrence-free survivalResidual breast cancerRisk of recurrenceFuture clinical trialsStructured exercise programImpact of exerciseAnti-angiogenic agentsUnmet medical needContribution of exerciseQuality of lifeYear BAdjuvant bevacizumabDFCI 05Eligible ptsLast surgeryNeoadjuvant chemotherapyPrimary endpoint
2010
Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma
Lustberg M, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg M, Villalona-Calero M. Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma. Journal Of Thoracic Oncology 2010, 5: 713-718. PMID: 20354452, PMCID: PMC3641556, DOI: 10.1097/jto.0b013e3181d7776d.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsCamptothecinCarcinoma, Squamous CellEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansIrinotecanLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMitomycinNeoplasm StagingStomach NeoplasmsSurvival RateTreatment OutcomeConceptsMitomycin CDay 1Day 2Phase II Randomized StudyComplete pathologic responsePhase II evaluationGastroesophageal junction adenocarcinomaUnresectable esophagealEvaluable patientsGastroesophageal adenocarcinomaJunction adenocarcinomaPathologic responseRandomized studyArm AGastroesophageal junctionFuture trialsEsophageal cancerII evaluationSevere toxicityPatientsIrinotecanResponse ratePhase IAdenocarcinomaTopoisomerase 1
2002
A Phase II Randomized Study of the Virologic and Immunologic Effect of Zidovudine + Stavudine versus Stavudine Alone and Zidovudine + Lamivudine in Patients with >300 CD4 Cells Who Were Antiretroviral Naive (ACTG 298)
Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A Phase II Randomized Study of the Virologic and Immunologic Effect of Zidovudine + Stavudine versus Stavudine Alone and Zidovudine + Lamivudine in Patients with >300 CD4 Cells Who Were Antiretroviral Naive (ACTG 298). AIDS Research And Human Retroviruses 2002, 18: 699-704. PMID: 12167276, DOI: 10.1089/088922202760072311.Peer-Reviewed Original ResearchConceptsCD4 cell countStandard of careD4TViral loadWeek 12Copies/Cell countMedian baseline viral loadPhase II Randomized StudyD4T armDual nucleoside therapyAntiretroviral-naive patientsBaseline viral loadWeeks of monotherapyViral load reductionTreatment of patientsDevelopment of multidrugAntiretroviral-NaiveAntiviral suppressionNaive patientsCD4 cellsImmunologic effectsHIV infectionRandomized studyNucleoside therapy
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