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@ARTICLE{Kuon:154603,
      author       = {J. Kuon and A. Hommertgen$^*$ and J. Krisam and F.
                      Lasitschka and A. Stenzinger and M. Blasi and F. Bozorgmehr
                      and M. Maenz and M. Kieser and M. Schneider and M. Thomas},
      title        = {{D}urvalumab in frail and elderly patients with stage four
                      non-small cell lung cancer: {S}tudy protocol of the
                      randomized phase {II} {DURATION} trial.},
      journal      = {Trials},
      volume       = {21},
      number       = {1},
      issn         = {1745-6215},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2020-00876},
      pages        = {352},
      year         = {2020},
      abstract     = {Elderly 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.},
      cin          = {E055},
      ddc          = {610},
      cid          = {I:(DE-He78)E055-20160331},
      pnm          = {315 - Imaging and radiooncology (POF3-315)},
      pid          = {G:(DE-HGF)POF3-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32321565},
      doi          = {10.1186/s13063-020-04280-8},
      url          = {https://inrepo02.dkfz.de/record/154603},
}