BX43361 - Malignant Tumours Master Screening Study

• Research type

  Research Study

• Full title

  MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORS

• IRAS ID

  314238

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Clinicaltrials.gov Identifier

  2021-004401-53, EUDRACT No.

• Duration of Study in the UK

  5 years, 5 months, 27 days

• Research summary

  Study BX43361 is a global, interventional, multicentre, master biomarker screening study. No drug treatment will be given to participants on this study.

  This screening study provides tissue biomarker testing to determine enrolled patients’ potential eligibility, based on their biomarker status, for a Roche-sponsored clinical trial linked to this master screening study.

  Tumour tissue samples from enrolled patients will be analysed using a central laboratory.

  Within the early-stage non small cell lung cancer (NSCLC) field, a number of studies and collaborations have successfully used a common screening platform, either within a master protocol design, or as a separate study to help identify appropriate patients to participate in clinical trials involving targeted therapies.

  This common screening approach aims to provide a more streamlined recruitment process into the linked treatment cohorts and studies for both patients and investigators, as well as potentially lower screen failure rates through access to validated broader biomarker testing.

  This master screening study will be conducted initially only to identify biomarker eligible patients with either locally advanced, unresectable Stage III NSCLC or Stage I to IIIA NSCLC requiring adjuvant treatment However, it is anticipated that this study will be amended in the future to include additional linked Roche clinical trials.

  The aim is to recruit approximately 15,000 patients into the study with up to 1,000 from the UK.
  The study will last approximately 10 years from first patient screened to end of study.
  The study is sponsored by F. Hoffmann- La Roche

  Research Summary; Version 1 dated 17-Mar-2022

• REC name

  Wales REC 5

• REC reference

  22/WA/0199

• Date of REC Opinion

  26 Jul 2022

• REC opinion

  Favourable Opinion