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Poster display session

2024 - Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (CRISP): a prospective German Registry in stage IV NSCLC AIO-TRK-0315)

Date

09 Sep 2017

Session

Poster display session

Topics

Cancers in Adolescents and Young Adults (AYA);  Targeted Therapy;  Non-Small Cell Lung Cancer

Presenters

Frank Griesinger

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

F. Griesinger1, W. Eberhardt2, N. Marschner3, M. Jänicke4, A. Fleitz4, L. Spring4, J. Sahlmann5, A. Karatas6, A. Hipper6, W. Weichert7, M. Sebastian8, M. Thomas9

Author affiliations

  • 1 Department Of Internal Medicine-oncology, Pius Hospital Oldenburg, University of Oldenburg, 26121 - Oldenburg/DE
  • 2 Department Of Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45122 - Essen/DE
  • 3 Oncology And Haematology, Praxis für interdisziplinäre Onkologie & Hämatologie, 79110 - Freiburg/DE
  • 4 Clinical Epidemiology And Health Economics, iOMEDICO AG, 79108 - Freiburg/DE
  • 5 Data Management , Statistics & Medical Informatics, iOMEDICO AG, 79108 - Freiburg/DE
  • 6 Aio-studien-ggmbh, AIO-Studien-gGmbH, 14057 - Berlin/DE
  • 7 Institute Of Pathology, Technical University Munich (TUM), Munich/DE
  • 8 Department Of Oncology And Haematology, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE
  • 9 Medical Oncology, Thoraxklinik Heidelberg, Heidelberg/DE
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Resources

Abstract 2024

Background

Treatment in NSCLC is quickly evolving and new agents make it to the routine practice at a rapid pace. Whether outcome and PRO data generated from clinical trials with often narrow inclusion and exclusion criteria will hold up in the routine practice is of high interest, especially due to the increasing costs of new drugs. Therefore registry data are of ever increasing importance to patients, physicians and reimbursement institutions.

Trial design

We have started a prospective, clinical registry to document representative data on molecular testing, sequences of systemic therapies and other treatment modalities, and course of disease in patients with metastatic NSCLC in Germany (CRISP, NCT02622581). A particular focus is on molecular biomarker testing of patients before the start of first-line treatment. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved. PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC. Furthermore CRISP will set up a decentral tissue annotation for future collaborative, investigational scientific biomarker testing. CRISP will be carried out in up to 150 representative cancer centers in all therapeutic sectors in Germany. More than 5000 patients will be recruited and followed up until death or for a maximum of 3 years. The first patient has been included in December 2015. Currently, 104 centers have been initiated, and 765 patients have been recruited. Preliminary data will be presented at the meeting in terms of molecular test rates, demographic data as well as treatment stratification in the 1st line setting. In conclusion: The registry CRISP will be the first to present representative real life data, covering all treatment settings of patients with NSCLC in Germany. CRISP is supported by AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, and Pfizer.

Clinical trial identification

NCT02622581

Legal entity responsible for the study

AIO-Studien-gGmbH, Berlin

Funding

AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, and Pfizer Pharma GmbH.

Disclosure

F. Griesinger: Advisory Board/Honoraria: Ariad, Astra-Zeneca, Boehringer-Ingelheim, Bristol-Myer-Squibb, Celgene, Clovis, Lilly, Merck-Sharp-Dome, Novartis, Pfizer, Roche N. Marschner: ADB: Amgen, Roche Honoraria: Amgen, Celgene, Roche research grants: Amgen, Celgene, stock ownweship/leadership position: iOMEDICO AG. M. Sebastian: Advisory boards: BMS, MSD, Roche, Novartis, AstraZeneca, Boehringer, Celgene, Lilly, Pfizer. M. Thomas: Honoraria/AD Boards: MSB, BMS, Lilly, Astrazeneca, Roche, Pfizer, Celgene, Novartis. All other authors have declared no conflicts of interest.

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