BO43249 MULTIPLE THERAPIES IN NSCLC PATIENTS

• Research type

  Research Study

• Full title

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

• IRAS ID

  1010946

• Contact name

  Head of Clinical Trails Regulatory Management

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann- La Roche AG

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  NCT06624059

• Research summary

  Lung cancer remains the leading cause of cancer deaths worldwide. Non-small cell lung cancer (NSCLC) is the predominant lung cancer subtype, accounting for >80% of lung cancer cases. The 5-year survival rate for NSCLC ranges from below 10% to more than 60%, depending on the stage at which the cancer diagnosis is made. Over 40% of patients with newly diagnosed NSCLC present with early-stage (Stage I-III) resectable disease, for which mortality can range from 27% in Stage IB to 76% in Stage IIIB.
  Surgery followed by treatment with up to four cycles of platinum-based chemotherapy has been a standard of care (SOC) for patient with larger primary tumours (>4cm) and those cancer that have spread to the lymph node in the chest to reduce the risk of the cancer coming back. Alternative approaches, namely the investigation of neoadjuvant and perioperative treatment strategies for patients with operable cancer, are being investigated to see if this improves the chance of cure. In the adjuvant, neoadjuvant, and perioperative approaches, the addition of immunotherapy and targeted therapies alone or in combination with chemotherapy are also being investigated.
  This study (BO43249) will enable the evaluation of adjuvant and/or neo-adjuvant or perioperative treatments in the early-stage resectable setting with specific biomarker that is treatable with a targeted treatment, where there continues to be an unmet medical need.

  The current protocol aims to recruit 150 participants with resectable, early-stage NSCLC, whose tumours have an eligible biomarker, in 2 groups initially but this may change as further biomarker specific groups are added.
  The study will last approximately 10 years based on the current cohorts however this may change as further cohorts are added.
  There will be approximately 15 patients recruited at 6 UK sites
  
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version Number 1 dated 04-Nov-2024

• REC name

  Wales REC 5

• REC reference

  24/WA/0364

• Date of REC Opinion

  17 Jan 2025

• REC opinion

  Further Information Favourable Opinion