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Poster session 14

1021P - DURATION - a phase II randomized trial in older / frail patients (pts) with advanced non-small cell lung cancer (NSCLC) comparing chemotherapy (CTX, 4 cycles) with CTX (2 cycles) and consecutive durvalumab (D): Top-line early efficacy endpoints


10 Sep 2022


Poster session 14


Cancer in Older Adults

Tumour Site

Non-Small Cell Lung Cancer


Jonas Kuon


Annals of Oncology (2022) 33 (suppl_7): S448-S554. 10.1016/annonc/annonc1064


J.B. Kuon1, M. Blasi2, K. Kokowski3, M. Faehling4, W. Schuette5, D.C.C. Christoph6, M. Kimmich7, W. Engel-Riedel8, J. Fischer9, M. Lehmann10, M. Ulmer11, P. Schuett12, N. Moosmann13, C. Meyer zum Bueschenfelde14, F. Griesinger15, M. Schneider16, R. Behnisch17, A. Stenzinger18, P. Christopoulos19, M. Thomas20

Author affiliations

  • 1 Thoracic Oncology Department, Thoraxklinik at Heidelberg University Hospital, 69126 - Heidelberg/DE
  • 2 Thoracic Oncology Department, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 3 Pneumooncology Department, Krankenhaus München Bogenhausen II Med. Abteilung, 81925 - Munich/DE
  • 4 Klinik Für Kardiologie Und Pneumologie, Klinikum Esslingen, 73730 - Esslingen am Neckar/DE
  • 5 Medical Oncology, Hospital Martha-Maria Halle-Doelau, 6120 - Halle (Saale)/DE
  • 6 Medical Oncology / Hematology Department, Kliniken Essen Mitte Evang. Huyssens-Stiftung, 45136 - Essen/DE
  • 7 Pneumologie Und Pneumologische Onkologie Abteilung, Robert-Bosch-Krankenhaus, 70376 - Stuttgart/DE
  • 8 Lung Clinic, Krankenhaus Merheim, 51109 - Köln/DE
  • 9 Thoracic Oncology Department, SLK-Kliniken Heilbronn GmbH, 74078 - Heilbronn/DE
  • 10 Thoracic Oncology Department, Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH, 58675 - Hemer/DE
  • 11 Medizinische Klinik I, Klinikum Ludwigsburg Medizinische Klinik I, 71640 - Ludwigsburg/DE
  • 12 Onkologie, Onkologische Schwerpunktpraxis, 33332 - Gütersloh/DE
  • 13 Oncology, Barmherzige Brueder Krankenhaus Regensburg, 93049 - Regensburg/DE
  • 14 Medical Department, St. Vincentius Hospital Medizinische Klinik II, 76137 - Karlsruhe/DE
  • 15 Oncology Department, Pius Hospital, 26121 - Oldenburg/DE
  • 16 Stf Research Unit, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 17 Biostatistics, Heidelberg University Hospital, 69120 - Heidelberg/DE
  • 18 Pathology, University Hospital Heidelberg, Institute of Pathology, 69120 - Heidelberg/DE
  • 19 Dept. Of Oncology Of Thoracic Tumors, Thoraxklinik Heidelberg gGmbH, 69126 - Heidelberg/DE
  • 20 Thoracic Oncology Department, Thoraxklinik Heidelberg gGmbH, 69126 - Heidelberg/DE

Abstract 1021P


Although frail and older pts represent a major fraction of NSCLC pts in routine clinical practice, this population is still underrepresented in clinical trials. The DURATION trial is a prospective, stratified, randomized, multicenter phase II study aiming to provide evidence on first line D after two cycles CTX in this population. Here we report the results for the efficacy endpoints within the first year of follow-up.


In this trial (NCT03345810), 201 pts diagnosed with stage IV NSCLC and ≥70 years of age and/or Charlson Comorbidity Index > 1 and/or performance status (PS) ECOG ≥ 2 were stratified according to the Cancer and Age Research Group (CARG) score in “fit” (combination CTX, cCTX) for CARG ≤3 and “unfit” (mono CTX, mCTX). After stratification pts were randomized 1:1 to receive 4 cycles of cCTX (n=49) versus 2 cycles of cCTX and D (cCTX-D, n=48) or 4 cycles of mCTX (n=52) versus 2 cycles of mCTX and D (mCTX-D, n=52).


The median age was 76 years (range 56-90), 131 pts (65%) were men, 59 pts (30%) had a PS ECOG ≥2. The PD-L1 expression was 0%, 1-49% and ≥50% in 42%, 51% and 7% of pts, respectively. Compared to the “unfit” group, “fit” pts showed longer progression free survival (PFS, HR 0.54, log-rank p<0.001) and overall survival (OS, HR 0.45, log-rank p<0.001). The 1-year PFS rate was 12% vs. 21% for cCTX and cCTX-D and 3% vs. 12% for mCTX and mCTX-D, while the 1-year OS was 53% vs. 41% for cCTX and cCTX-D and 22% vs. 24% for mCTX and mCTX-D, respectively. The median PFS was 6 and 5 months (mo) for cCTX and cCTX-D (log-rank p= 0.921) and 4 and 3 mo for mCTX and mCTX-D (log-rank p= 0.951), respectively. The median OS was not reached for cCTX and 10 mo for cCTX-D (log-rank p=0.142), while it was 6 and 5 mo for mCTX and mCTX-D (log-rank p=0.995), respectively.


cCTX or mCTX according to risk stratification (CARG score) with two cycles followed by D showed an antitumor activity comparable to those of 4 cycles of standard CT in the frontline treatment of older and/or frail stage IV NSCLC pts. The results of the safety primary endpoint for this trial are pending.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

AIO StudiengGmbH.


AstraZeneca, BMS.


J.B. Kuon: Non-Financial Interests, Institutional, Research Grant: AstraZeneca. All other authors have declared no conflicts of interest.

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