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.
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
Legal entity responsible for the study
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.
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.