GO41767 - Tiragolumab in untreated extensive-stage SCLC

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB PLUS CARBOPLATIN AND ETOPOSIDE WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER

• IRAS ID

  273692

• Contact name

  Raffaele Califano

• Contact email

  raffaele.califano@christie.nhs.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2019-003301-97

• Duration of Study in the UK

  3 years, 4 months, 2 days

• Research summary

  Lung cancer remains the leading cause of cancer deaths worldwide. Small cell lung cancer (SCLC) accounts for approximately 15% of all cases and is distinguished from non-small cell lung cancer (NSCLC) by its rapid growth rate and early development of metastatic disease.
  Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival, though a majority will relapse. The majority (approximately 70%)of patients with SCLC are diagnosed with extensive-stage disease (ES-SCLC),which has poor survival prospects. Chemotherapy alone can palliate symptoms and prolong survival for patients with ES-SCLC; however, long-term survival is rare.

  The current standard first-line treatment for patients with ES-SCLC is the PD-L1 inhibitor atezolizumab given with platinum-based chemotherapy (CE).Despite the improved efficacy observed with first-line atezolizumab plus CE, most patients with ES-SCLC experience disease progression their prognosis is poor. Therefore, novel strategies are needed to deliver better long-term survival.

  TIGIT (a receptor found on the surface of activated T-Cells) is expressed in a wide variety of human tumours and is highly correlated with T-cell infiltration and PD-1 expression. Agents that inhibit the activity of TIGIT may relieve an important source of tumour-associated immune suppression may enhance the activity of other immune-based therapies, such as atezolizumab. Tiragolumab is a monoclonal antibody that binds TIGIT. It is being investigated as a potential therapy against tumours in humans.

  The aim of this study is to evaluate the safety and efficacy of tiragolumab given with atezolizumab and CE compared with placebo given with atezolizumab and CE in patients who have ES-SCLC and are chemotherapy naive for their extensive-stage disease.
  400 patients will be recruited globally with approximately 13 from the UK across 6/7 sites.

  The study will last approximately 43 months from FPI to LPLV.
  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 1 dated 12 Nov 2019

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  20/NE/0032

• Date of REC Opinion

  19 Feb 2020

• REC opinion

  Further Information Favourable Opinion