CA209-026 Nivolumab in advanced NSCLC

• Research type

  Research Study

• Full title

  CA209-026: An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator’s Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (NSCLC)

• IRAS ID

  148241

• Contact name

  Clive Mulatero

• Contact email

  clive.mulatero@leedsth.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb Iterationasl Corporation

• Eudract number

  2012-004502-93

• Research summary

  CA209-026: A clinical trial involving an investigational immunotherapy drug, nivolumab, versus standard of care chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)

  Lung cancer is the second most common cancer in the UK and the most common cause of cancer related deaths in men and women. Worldwide nearly 1.2 million people die from lung cancer each year. A significant number of patients have advanced lung cancer at diagnosis. Unfortunately with current standard of care chemotherapy treatments, the survival rate remains poor with less than 5% of advanced lung cancer patients alive five years on from diagnosis. There is a clear unmet medical need for patients with advanced NSCLC.

  Nivolumab, a BMS experimental drug currently in development, is a new type of immunotherapy drug which stimulates the body’s own immune system to help attack cancer cells. It works by blocking a protein on the body’s immune cells, called PD-1, so that tumours can be recognised as foreign and attacked by the immune system.
  Following a screening period, eligible patients will either receive nivolumab every 2 weeks or standard chemotherapy every 3 weeks according to standard clinical practice. Patients will receive nivolumab until their cancer gets worse or their doctor decides they should come out of the study. Patients who receive chemotherapy in the study may be eligible to receive nivolumab if their cancer gets worse. Patients will undergo the following procedures during the study: tumour tissue biopsy, CT/MRI scans, physical exams, vital signs read and blood drawn for routine safety testing and study specific testing.

  Patients will be treated by trained oncology teams in specialised NHS clinics. It is planned for 495 patients to be treated in the study worldwide with approximately 12 being treated in the UK. The study is sponsored by Bristol-Myers Squibb.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/0101

• Date of REC Opinion

  28 Apr 2014

• REC opinion

  Further Information Favourable Opinion