BO42592 Tiragolumab in non-squamous NSCLC

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NONSMALL CELL LUNG CANCER

• IRAS ID

  288026

• Contact name

  Farah Louise Lim

• Contact email

  farahlouise.lim@nhs.net

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-002851-39

• Clinicaltrials.gov Identifier

  NCT04619797

• Duration of Study in the UK

  4 years, 10 months, 30 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). NSCLC can be divided into two subcategories: squamous and non-squamous with squamous cell accounting for approximately 25% of NSCLC.

  The standard-of-care first-line (1L) treatment for advanced non-squamous NSCLC is largely driven by results of molecular profiling. Preferred 1L treatment for patients with tumours with an oncogenic mutation is an approved targeted therapy. For patients whose tumours lack a targetable oncogenic mutation, current standard of care 1L regimens typically include PD-L1/PD-1 blocking antibodies, with or without platinum-based doublet chemotherapy and bevacizumab. Despite therapeutic advances, the majority of patients with advanced non-squamous NSCLC progress on currently available treatment options ultimately experience disease progression and succumb to this disease. Therefore, high unmet medical need persists for advanced non-squamous NSCLC.

  In this clinical trial, we are using two different types of immunotherapy together, atezolizumab and tiragolumab plus chemotherapy compared with placebo and the current standard of care (pembrolizumab plus chemotherapy). The combination of tiragolumab with atezolizumab plus chemotherapy in the experimental arm can represent a potentially valuable treatment option and can offer a reasonable benefit/risk balance for patients in this study. Atezolizumab binds a protein called PD-L1 and is already used in lung cancer, and tiragolumab binds a protein called TIGIT and activates the immune system in a novel way.

  The aim is to recruit 200 patients globally with 36 from the UK. Half of these patients will receive atezolizumab and tiragolumab plus chemotherapy and the other half will receive standard of care pembrolizumab plus chemotherapy.

  The study will last approximately 5 years from FPI to LPLV.
  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version 1 dated 13-Aug-2020

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  20/EE/0251

• Date of REC Opinion

  9 Dec 2020

• REC opinion

  Further Information Favourable Opinion