Efficacy of Durvalumab/Tremelimumab with SoC chemo in metastatic NSCLC
Research type
Research Study
Full title
A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non-Small-Cell Lung Cancer (NSCLC)(POSEIDON)
IRAS ID
228153
Contact name
Siow-Ming Lee
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-000920-81
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 20 days
Research summary
This study is being conducted to compare a potential new treatment for patients who have certain type of Non Small-Cell Lung Cancer (NSCLC). The study will aim to determine how effective the new treatments, (durvalumab, or durvalumab and tremelimumab) in combination with chemotherapy, are in the first-line treatment of these patients in comparison with the currently available treatment. The new treatments aim to enhance the body’s natural defence to a tumour. It is hoped that this new treatment will more effective, but this is not known at present which is why the study is being performed.
The study will include about 801 subjects and will be conducted at sites with expertise in the treatment of lung cancer. In order to take part, patients must be aged 18 years or above and have advanced lung cancer. A fresh tissue sample (biopsy) is required which must taken in the 3 months before a patient joins the study.
Patients will be randomly assigned to one of three treatment groups:
• durvalumab and tremelimumab combination therapy + chemotherapy
• durvalumab monotherapy + chemotherapy
• chemotherapy alone.Each new treatment will be given directly in to a vein, over the course of 3-4 hours.
Patients who are eligible for the study will visit the hospital site for about one day every 3 weeks for the first 12-16 weeks whilst completing chemotherapy. After chemotherapy visits will be monthly and for about half a day. At each visit they will undergo various tests such as physical exams, blood and urine and Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scans of their tumours.
When a patient stops study treatment and the associated intensive monitoring ends, they will remain in the study for long term follow up of their disease outcome.
The study is anticipated to continue until August 2021.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0264
Date of REC Opinion
16 Aug 2017
REC opinion
Further Information Favourable Opinion