GO41854 - Atezolizumab plus Tiragolumab vs Durvalumab in NSCLC

• Research type

  Research Study

• Full title

  A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB AND TIRAGOLUMAB COMPARED WITH DURVALUMAB IN PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER CONCURRENT PLATINUM-BASED CHEMORADIATION (SKYSCRAPER-03)

• IRAS ID

  279531

• Contact name

  Gary Doherty

• Contact email

  gary.doherty@addenbrookes.nhs.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2019-004773-29

• Duration of Study in the UK

  7 years, 4 months, 8 days

• Research summary

  Lung cancer remains the leading cause of cancer deaths worldwide. Most(85%)of patients with lung cancer have a particular type called non-small cell lung cancer(NSCLC).
  When patients with NSCLC are diagnosed,about one fifth of patients have what is known as Stage III NSCLC,this means that the disease has spread locally,but has not gone to other organs. Some stage III patients can undergo surgery to help improve their survival,while for others this is not possible or appropriate,and the best first treatment that can be offered to improve their survival(for patients who are well enough to receive this)is a combination of chemotherapy and radiotherapy (known as concurrent chemoradiotherapy or CRT),followed by up to one year of immunotherapy with a drug called durvalumab. Despite these treatments,around half of patients still die of lung cancer in the next three years,highlighting an important need for new ways to improve patient survival.
  In this clinical trial,we are using two different types of immunotherapy together(atezolizumab,which binds a protein called PD-L1 and is already used in lung cancer treatment,and tiragolumab,which binds a protein called TIGIT and activates the immune system in a novel way). We believe these may work well together to help patients’ immune systems kill lung cancer cells and improve their outcomes.
  We aim to recruit 800 patients globally(with 32 from the UK)with stage III NSCLC to this trial if they have not had tumour growth after their CRT treatment. We will give half of these patients durvalumab(standard treatment)and give the other half atezolizumab and tiragolumab. We will monitor patients closely to see if there are differences in how their cancers respond to treatment,as well as side effects from treatment.

  The study will last approximately 90 months from FPI to LPLV.
  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version 1 dated 26-May-2020

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  20/NE/0171

• Date of REC Opinion

  6 Jul 2020

• REC opinion

  Further Information Favourable Opinion