PACIFIC-8
Research type
Research Study
Full title
A Phase III, Randomized, Doubleblind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8)
IRAS ID
1005925
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-004327-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn more about how effective and safe durvalumab (MEDI4736) in combination with domvanalimab (AB154) is, 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 domvanalimab. Domvanalimab is an immunotherapy that works via different mechanisms to durvalumab to prevent tumours from evading the immune system. Domvanalimab blocks a second pathway that stops the immune system from killing cancer cells. Combining durvalumab with domvanalimab 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 two treatment arms: durvalumab plus domvanalimab or durvalumab plus placebo. Approximately 860 participants will be randomised in approximately 22 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 8 years globally.REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0169
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Favourable Opinion