GO45006 - Tiragolumab and Atezolizumab Co-Infusion in Early Stage Lung Cancer

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB COMPARED WITH PLACEBO PLUS ATEZOLIZUMAB IN PARTICIPANTS WITH COMPLETELY RESECTED STAGE IIB, IIIA, OR SELECT IIIB, PD-L1 POSITIVE, NON-SMALL CELL LUNG CANCER WHO HAVE RECEIVED ADJUVANT PLATINUM-BASED CHEMOTHERAPY

• IRAS ID

  1008982

• Contact name

  Samy Chabri

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2023-506696-10

• Clinicaltrials.gov Identifier

  NCT06267001

• Research summary

  Lung cancer remains the leading cause of cancer deaths worldwide. In 2023 in the United States, it is estimated that there will be 238,340 new cases of lung cancer and 127,070 lung cancer deaths. Data from Europe estimate that in 2023 there will be 159,057 lung cancer deaths.
  Non-small cell lung cancer is the predominant subtype of lung cancer, accounting for approximately 80%-85% of all cases. In its early stages, NSCLC is treated surgically with curative intent. However, 30%-70% of patients undergoing resection develop recurrence and die as a result of disease progression. For Stage II to IIIB disease, the development of platinum-based chemotherapy has led to its use as adjuvant or neoadjuvant therapy together with surgery to improve survival outcome compared with surgery alone. Recently, neoadjuvant and adjuvant approaches with either targeted or immunotherapy agents in combination or following chemotherapy for fully resected (Stage II to IIIB) NSCLC have been approved and are emerging as the next SOC, However a significant proportion of participants still experience disease re-occurrence; hence, continued research of novel candidates and combinations are warranted.

  This is a Phase III, randomized, double-blind, global, multicenter study designed to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered in participants with PD-L1 > 1% TC Stage IIB, IIIA, or select IIIB (T3N2 only) NSCLC following resection and adjuvant platinum-based chemotherapy.
  Globally 1150 participants will be enrolled with 25 from the UK across 7 sites.
  The study will last approximately 15 years from FPI to LPLV, with each participant expected to be treated for a maximum of 13 cycles but will be scanned and followed up for up to 15 years.
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version Number 1 dated 20-Mar-2024

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  24/EM/0117

• Date of REC Opinion

  21 Jun 2024

• REC opinion

  Further Information Favourable Opinion