000154603 001__ 154603
000154603 005__ 20240229123107.0
000154603 0247_ $$2doi$$a10.1186/s13063-020-04280-8
000154603 0247_ $$2pmid$$apmid:32321565
000154603 0247_ $$2ISSN$$a1468-6694
000154603 0247_ $$2ISSN$$a1468-6708
000154603 0247_ $$2ISSN$$a1745-6215
000154603 0247_ $$2altmetric$$aaltmetric:80703419
000154603 037__ $$aDKFZ-2020-00876
000154603 041__ $$aeng
000154603 082__ $$a610
000154603 1001_ $$aKuon, Jonas$$b0
000154603 245__ $$aDurvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial.
000154603 260__ $$aLondon$$bBioMed Central$$c2020
000154603 3367_ $$2DRIVER$$aarticle
000154603 3367_ $$2DataCite$$aOutput Types/Journal article
000154603 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1588078797_27794
000154603 3367_ $$2BibTeX$$aARTICLE
000154603 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000154603 3367_ $$00$$2EndNote$$aJournal Article
000154603 520__ $$aElderly patients represent a major fraction of non-small cell lung cancer (NSCLC) patients in routine clinical practice, but they are still underrepresented in clinical trials. In particular, data regarding efficacy and safety in frail or elderly patients with respect to immunotherapy are lacking. Importantly, immunosenescence in elderly patients might interfere with activities of immune-modulating drugs such as PD-1/PD-L1 inhibitors. Thus, there is an urgent need to assess safety and efficacy of such inhibitors in this group.This prospective, open label, treatment stratified, randomized phase II study will enroll 200 patients with stage IV NSCLC amenable at least to single-agent chemotherapy (CT). Eligible patients must be aged 70 years or older and/or 'frail' (Charlson Comorbidity Index > 1) or have a restricted performance status (Eastern Cooperative Oncology Group, ECOG > 1). Patients are stratified according to modified Cancer and Age Research Group (CARG) score: 'fit' patients are allocated to combination CT (carboplatin/nab-paclitaxel) and 'less fit' patients receive single-agent CT (gemcitabine or vinorelbine). After allocation to strata, patients are randomized 1:1 to receive either four cycles of CT or two cycles of CT followed by two cycles of durvalumab and subsequent maintenance treatment with durvalumab every 4 weeks. The primary endpoint is the rate of treatment-related grade III/IV adverse events (Common Terminology Criteria for Adverse Events (CTCAE) V4.03). As secondary endpoints, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, response rate (RR), overall survival (OS), descriptive subgroup analyses according to PD-L1 expression, and quality of life are addressed. Geriatric screening assessments and functional tests will be performed to complete the phenotyping of a potential 'frail' and 'elderly' patient cohort. The trial is accompanied by a biomaterial repository to explore potential biomarkers.The DURATION trial will prospectively investigate the safety and tolerability of anti-PD-L1 treatment with durvalumab after chemotherapy in elderly and frail patients and thereby provide new insights into the effect of PD-L1 blockade and the impact of immunosenescence in this cohort of patients.ClinicalTrials.gov, NCT03345810; initially registered on 17 November 2017. Eudra-CT, 2016-003963-20; initially registered on 3 January 2017.
000154603 536__ $$0G:(DE-HGF)POF3-315$$a315 - Imaging and radiooncology (POF3-315)$$cPOF3-315$$fPOF III$$x0
000154603 588__ $$aDataset connected to CrossRef, PubMed,
000154603 7001_ $$0P:(DE-He78)cce6b51dcd85173b43b8b662ea47c700$$aHommertgen, Adriane$$b1
000154603 7001_ $$aKrisam, Johannes$$b2
000154603 7001_ $$aLasitschka, Felix$$b3
000154603 7001_ $$aStenzinger, Albrecht$$b4
000154603 7001_ $$aBlasi, Miriam$$b5
000154603 7001_ $$aBozorgmehr, Farastuk$$b6
000154603 7001_ $$aMaenz, Martin$$b7
000154603 7001_ $$aKieser, Meinhard$$b8
000154603 7001_ $$aSchneider, Marc$$b9
000154603 7001_ $$aThomas, Michael$$b10
000154603 773__ $$0PERI:(DE-600)2040523-6$$a10.1186/s13063-020-04280-8$$gVol. 21, no. 1, p. 352$$n1$$p352$$tTrials$$v21$$x1745-6215$$y2020
000154603 909CO $$ooai:inrepo02.dkfz.de:154603$$pVDB
000154603 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)cce6b51dcd85173b43b8b662ea47c700$$aDeutsches Krebsforschungszentrum$$b1$$kDKFZ
000154603 9131_ $$0G:(DE-HGF)POF3-315$$1G:(DE-HGF)POF3-310$$2G:(DE-HGF)POF3-300$$3G:(DE-HGF)POF3$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vImaging and radiooncology$$x0
000154603 9141_ $$y2020
000154603 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bTRIALS : 2017
000154603 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS
000154603 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline
000154603 915__ $$0StatID:(DE-HGF)0320$$2StatID$$aDBCoverage$$bPubMed Central
000154603 915__ $$0StatID:(DE-HGF)0501$$2StatID$$aDBCoverage$$bDOAJ Seal
000154603 915__ $$0StatID:(DE-HGF)0500$$2StatID$$aDBCoverage$$bDOAJ
000154603 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bDOAJ : Open peer review
000154603 915__ $$0LIC:(DE-HGF)CCBYNV$$2V:(DE-HGF)$$aCreative Commons Attribution CC BY (No Version)$$bDOAJ
000154603 915__ $$0StatID:(DE-HGF)0600$$2StatID$$aDBCoverage$$bEbsco Academic Search
000154603 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bASC
000154603 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List
000154603 915__ $$0StatID:(DE-HGF)0111$$2StatID$$aWoS$$bScience Citation Index Expanded
000154603 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection
000154603 915__ $$0StatID:(DE-HGF)1110$$2StatID$$aDBCoverage$$bCurrent Contents - Clinical Medicine
000154603 915__ $$0StatID:(DE-HGF)9900$$2StatID$$aIF < 5
000154603 9201_ $$0I:(DE-He78)E055-20160331$$kE055$$lE055 KKE Translationale Radioonkologie$$x0
000154603 980__ $$ajournal
000154603 980__ $$aVDB
000154603 980__ $$aI:(DE-He78)E055-20160331
000154603 980__ $$aUNRESTRICTED