143TiP - SPECTAlung: Screening patients with thoracic tumors for efficient clinical trial access

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Drug Development
Non-Small-Cell Lung Cancer, Metastatic
Translational Research
Presenter Benjamin Besse
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors B. Besse1, J. Menis2, J. Adam3, R. Dziadziuszko4, B. Hasan5, L. Lacroix6, S. Peters7, D.A. Lacombe8, M. O'Brien9, R.A. Stahel10
  • 1Department Of Cancer Medicine, Gustave Roussy Cancer Campus Grand Paris, 94805 - Villejuif/FR
  • 2Medical Department, European Organization for Research and Treatment of Cancer (EORTC), Brussels/BE
  • 3Pathology Department, Gustave Roussy Cancer Campus Grand Paris, Villejuif/FR
  • 4Dept. Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
  • 5Statistical Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels/BE
  • 6Department Of Medical Biology And Pathology, Translational Research Laboratory And Biobank (ums3655 Cnrs /us23 Inserm), Gustave Roussy Cancer Campus Grand Paris, Villejuif/FR
  • 7Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne/CH
  • 8Medical, European Organisation for Research and Treatment of Cancer (EORTC), Brussels/BE
  • 9Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, London/UK
  • 10Clinic For Oncology, University Hospital Zuerich, Zurich/CH

Abstract

Background

SPECTAlung is a screening program of the European Organization for the Research and Treatment of Cancer (EORTC) in collaboration with the European Thoracic Oncology Platform (ETOP) for efficient clinical trial access for patients with thoracic tumors. Screening for molecular alteration is center/country dependent, and limited to a small subset of genes. Running clinical trials in small subsets of patients is challenging also because of lack of uniform testing program. SPECTAlung is the first European standardized, quality-assured molecular testing platform for thoracic tumor characterization with the overall goal of giving access to specifically targeted downstream clinical trials.

Trial design

After consenting, existing tumor tissue will be collected, centralized and processed according to defined international quality control standards at Gustave Roussy Biobank (Villejuif, Fr). Next Generation Sequencing (NGS) will be performed at Sanger Institute (Cambridge, UK) where a panel of 360 genes will be analyzed for mutations, rearrangements and gene copy number. Eligible patients will be those having a pathological diagnosis of any thoracic tumor (lung cancer, malignant pleural mesothelioma and thymic malignancies) at any stage of disease evolution, availability of tumor tissue, age ≥ 18 years, PS 0-2, life expectancy > 3months, no active malignancy in the 5 years before study entry and absence of any exclusion criteria that may prevent inclusion into clinical trials. NGS results will be sent to EORTC, a molecular report will be then released to the investigator highlighting the trials in which the patients might be eligible. The study will be active and recruiting, as soon as approved by ethic committees, in 15 selected highly specialized and qualified thoracic centres in 12 countries in Europe. SPECTAlung is expected to test 500-1000 patients each year, EORTC and ETOP will promote the implementation of clinical trials in molecularly selected groups of patients at the SPECTAlung centers. SPECTAlung offers innovative and attractive models of collaboration with commercial and research organizations and therefore is as a unique platform for supporting the development of personalized medicine and a first in class partnership model.

Clinical trial identification NCT02214134

Disclosure

All authors have declared no conflicts of interest.