PACIFIC-9
Research type
Research Study
Full title
A Phase III, double-blind, placebo-controlled, Randomized, Multicenter, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9)
IRAS ID
1004548
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-004346-37
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn more about the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiotherapy (cCRT). The addition of the immunotherapy durvalumab following cCRT was established as standard of care in this setting because of improved survival in a previous clinical trial. Nonetheless, a significant medical need still exists to improve outcomes for patients with this disease. This may be achieved by the addition of another immunotherapy agent such as monalizumab or oleclumab. These are immunotherapies that work via different mechanisms to durvalumab to prevent tumours from evading the immune system. Oleclumab prevents the production of adenosine, which tumours use to evade immune detection. Monalizumab works by blocking a signal that prevents Natural Killer (NK) and other immune cells from detecting cancer cells. Combining durvalumab with monalizumab or oleclumab may further enhance the ability of the immune system to recognize and kill cancer cells. Patients that meet the screening criteria will be randomly assigned to one of three treatment arms: durvalumab plus oleclumab, durvalumab plus monalizumab, or durvalumab plus placebo. Approximately 999 participants will be randomised in approximately 20 countries across North and South America, Europe and Asia. This study involves screening, treatment and follow-up (after study treatment is discontinued) periods. Patients who decide to take part in the study will have to attend regular clinic visits for drug infusions, physical exams, as well as blood, urine and other safety tests, along with completion of questionnaires, blood oxygen measurements and imaging scans for cancer measurement. The research study is planned to go on for about 9 years.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0045
Date of REC Opinion
18 Mar 2022
REC opinion
Further Information Favourable Opinion