Medi4736 and Tremelimumab in Non Small Cell Lung Cancer

• Research type

  Research Study

• Full title

  A Phase III Randomized, Open-Label, Multi-Center, Global Study of Medi4736 in Combination with Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Non-Small-Cell-Lung Cancer

• IRAS ID

  187687

• Contact name

  Peter Schmid

• Contact email

  p.schmid@qmul.ac.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2015-002197-21

• Clinicaltrials.gov Identifier

  NCT02542293

• Duration of Study in the UK

  2 years, 9 months, 7 days

• Research summary

  This study is being conducted to compare a potential new treatment for patients who have Non Small-Cell Lung Cancer (NSCLC). The study will aim to determine if the new treatments are better than the currently available treatment, chemotherapy. The new treatments aim to enhance the body’s natural defence that is immune reaction, to a tumour. It is hoped that this new treatment will be more effective and have less side effects than chemotherapy, but this is not known at present which is why the study is being performed.

  The study will be conducted at sites with expertise in the treatment of lung cancer. In order to be able to take part patients must be aged 18 years or above and have advanced lung cancer for which chemotherapy is the treatment option recommended by their Doctor. A fresh tissue sample (biopsy) is required which must be taken in the 3 months before a patient joins the study.

  Patients will be randomly assigned to one of 2 treatment groups:

  • MEDI4736 in combination with tremelimumab – for a 12-month period.
  • Chemotherapy – for 4 to 6 initial cycles. Some patient may remain on chemotherapy longer if their Doctor decides they are benefitting.
  The treatment will be given directly into a vein, over the course of 1-2 hours.

  Patients who are eligible for the study will visit the hospital site around once a month and will be there between half and one day. During that time they will undergo various tests such as blood and urine tests, Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scans of their tumours, and physical examinations.

  When study treatment and the associated intensive monitoring ends, patients will remain in the study for long term follow up of their disease outcome.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  15/EE/0385

• Date of REC Opinion

  13 Nov 2015

• REC opinion

  Further Information Favourable Opinion