Double-Blind, Efficacy and Safety of Durvalumab plus Olaparib
Research type
Research Study
Full title
A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)
IRAS ID
256190
Contact name
Hannah Lord
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-003460-30
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 1 months, 14 days
Research summary
The purpose of this research study is to test how well the study medication, Durvalumab, works in combination with Olaparib compared with Durvalumab Monotherapy in patients with First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).
Lung cancer has been the most common cancer in the world for several decades and was also the most common cause of death from cancer in 2012. Unfortunately, at the time of diagnosis approximately 70% of patients with NSCLC have advanced or metastatic disease not suitable to potentially curative surgery. Furthermore, approximately 50% of patients with early-stage NSCLC who have undergone surgery, develop distant recurrence and die as a result of NSCLC.
Both durvalumab (trade name ImfinziTM) and olaparib (trade name Lynparza™) are approved drugs by United States Food and Drug Administration (US FDA). Durvalumab has not been registered or approved within the EU and UK for treatment for NSCLC. Olaparib is centrally approved for the whole of the EU and is approved for certain patients with ovarian and breast cancer, but is not approved for lung cancer. Therefore, both durvalumab and olaparib are considered experimental treatments for patients with metastatic NSCLC.
Approximately 350 to 400 patients with metastatic non-small cell lung cancer from about 15 countries will take part in the research study. There will be around 350 to 400 patients who will receive durvalumab + chemotherapy, and then, around 250 patients will continue further into the study to receive durvalumab + placebo or durvalumab + olaparib in the maintenance setting. The study will last approximately 4 years. Procedures will include, but are not limited to, blood tests, vital signs, a test to measure heart activity (electrocardiogram), Radiological or MRI Scans to measure their tumour and assess the extent of the cancer and answering questions about quality of life.
AstraZeneca is funding the research.REC name
HSC REC B
REC reference
18/NI/0224
Date of REC Opinion
18 Jan 2019
REC opinion
Further Information Favourable Opinion