BO42777 - Multiple Therapies in Unresectable NSCLC

• Research type

  Research Study

• Full title

  A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCER

• IRAS ID

  1004770

• Contact name

  Head EU Product Development Pharmaceuticals Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann La Roche Ltd.

• Eudract number

  2021-004149-19

• Clinicaltrials.gov Identifier

  NCT05170204

• Research summary

  Lung cancer remains the leading cause of cancer-related deaths worldwide accounting for approx.11.6% of all new cancers (2018).Non-small cell lung cancer(NSCLC)is the predominant subtype, accounting for approximately 85% of all lung cancer cases.The overall 5-year survival rate for NSCLC ranges from 16-25%.Approx.30% of newly diagnosed patients with NSCLC have Stage III, unresectable disease.
  Until recently, the standard of care for patients with Stage III, unresectable NSCLC was definitive platinum-based chemotherapy and concurrent thoracic radiotherapy(cCRT) but although this treatment was intended to be curative, most patients ultimately died of their disease.Therapeutic outcomes in this population have improved with the approval of consolidation immunotherapy with durvalumab, but despite these recent advances, a substantial proportion of patients(44%) continue to progress within 12 months of commencing consolidation durvalumab treatment, post-chemo-radiation.
  There is an unmet medical need for new therapies for this indication and the evaluation of targeted therapies for locally advanced, unresectable disease in patients with oncogenic alterations is appropriate because this approach has proven to be highly effective in treating advanced or metastatic disease and when used as adjuvant therapy.
  With increasing availability and standardization of molecular testing techniques in oncology clinical practice, patients with tumours harbouring specific mutations can be identified and have the opportunity to receive targeted therapies tailored to those alterations.
  Study BO42777 is a Phase I-III, global, multicohort study to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status.
  Aim is to recruit 320 patients across 3 current cohorts with 13 from the UK.
  Study will last approx.11 years from FPI to LPLV. Sponsored by F. Hoffman La Roche. Research Summary V1 25-APR-22

• REC name

  Wales REC 5

• REC reference

  22/WA/0198

• Date of REC Opinion

  22 Aug 2022

• REC opinion

  Further Information Favourable Opinion