ADRIATIC - Tremelimumab &/or Durvalumab for patients with LS SCLC
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
IRAS ID
281971
Contact name
Hannah Pollard
Contact email
Eudract number
2018-000867-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
This study is being conducted to compare a potential new treatment for patients with limited stage small-cell lung cancer (LS-SCLC). This study is to determine how safe and effective the new treatment, durvalumab in combination with tremelimumab is in treating patients with LS-SCLC in comparison with durvalumab alone or with a placebo. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the immune cells to prevent / slow down cancer growth. Giving durvalumab with tremelimumab together may work better than durvalumab alone in treatment for patients with LS-SCLC.
The study will include about 600 patients globally and will be conducted at sites with expertise in the treatment of LS-SCLC. In order to take part, patients must be aged 18 or older and have LS-SCLC and have not got worse following platinum-based chemotherapy with radiotherapy and also meet some other criteria.
Patients and their study doctors will not know what treatment they are receiving and will be randomly assigned to one of the three treatment groups:
- Durvalumab + Tremelimumab combination treatment
- Durvalumab alone
- Placebo
The treatment is given into the vein for approximately an hour.
Patients will visit the clinic approximately every 4 weeks for up to 2 years and at each visit, patients will undergo various procedures such as physical examination and laboratory tests. Imaging of their disease will be done every 3 months. Biopsy samples will be taken, and patients will be asked to provide urine and stool samples.
After the end of study treatment when the associated intensive monitoring ends, patients remain in the study in order to follow up of their disease outcomes.
The study is anticipated to continue until 2024.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0241
Date of REC Opinion
30 Jul 2020
REC opinion
Further Information Favourable Opinion