MO29978 NIS PD-L1 Expression in Cyto & Histo Samples in NSCLC & SCLC

  • Research type

    Research Study

  • Full title

    A NON-INTERVENTIONAL MULTINATIONAL STUDY TO ASSESS PD-L1 EXPRESSION IN CYTOLOGICAL VERSUS HISTOLOGICAL NON-SMALL CELL OR SMALL CELL LUNG CANCER SPECIMENS

  • IRAS ID

    221849

  • Contact name

    Head, EU/ROW Regulatory Affairs Pharmaceutical Division

  • Contact email

    welwyn.eudract@roche.com

  • Sponsor organisation

    F Hoffmann-La Roche Ltd

  • Duration of Study in the UK

    1 years, 1 months, 31 days

  • Research summary

    Approximately 1.6 million individuals are diagnosed with lung cancer each year. Individuals diagnosed with lung cancer have a high mortality rate. Current lung cancer treatment is based on how big the cancer has grown and the cancer spread at the time of diagnosis. There are new/recent immunotherapy therapeutic interventions known as PD-L1/PD1 immune therapies currently used to treat lung cancer. The aim of this study is to compare two different types of tumour samples. Tissue (histology) samples with cell (cytology) in patients diagnosed with lung cancer (non-small cell or small cell lung cancer). The researchers would like to look at both samples in a research laboratory to find out the expression of a PD-L1 biomarker and other cancer related biomarkers that may be present in lung cancer tissue and cell samples. The PD-L1 biomarker is a protein within the body which can measure the presence of the molecule which may be indicative of the tumour and potential treatment the tumour may respond to. The researchers would like to understand whether they can use a cell samples (cytology collection, less invasive procedure) samples in replacement to tissue samples (histology collection, more invasive procedure) for identifying the PD-L1 and associated biomarker (proteins that are markers within the body) in patients with lung cancer. The information may help improve diagnostic testing of lung cancer patients in the future.

  • REC name

    North West - Greater Manchester East Research Ethics Committee

  • REC reference

    17/NW/0121

  • Date of REC Opinion

    27 Feb 2017

  • REC opinion

    Favourable Opinion