Durvalumab + Oleclumab/Monalizumab for Lung Cancer
(PACIFIC-9 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing two drug combinations to help the immune system fight advanced lung cancer that can't be surgically removed. The patients have already had previous treatment without their disease getting worse. The drugs aim to boost the immune response to better identify and kill cancer cells.
Will I have to stop taking my current medications?
The trial requires that you stop using immunosuppressive medications (drugs that lower the body's ability to fight infections) within 14 days before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What safety data exists for Durvalumab and related treatments in humans?
Durvalumab, also known as Imfinzi, has been studied for safety in various cancers. In the PACIFIC trial for lung cancer, about 25% of patients experienced immune-related side effects, with serious cases in 3.4% of patients. Other studies show that combining Durvalumab with another drug, Tremelimumab, increases the risk of serious side effects compared to using Durvalumab alone.12345
How is the drug combination of Durvalumab, Oleclumab, and Monalizumab unique for lung cancer?
This drug combination is unique because it builds on the standard treatment of durvalumab, an immune checkpoint inhibitor, by adding oleclumab and monalizumab, which target different immune pathways to potentially enhance the immune response against cancer cells in patients with stage III non-small cell lung cancer.56789
What data supports the effectiveness of the drug combination Durvalumab, Oleclumab, and Monalizumab for lung cancer?
Who Is on the Research Team?
Fabrice Barlesi, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
Are You a Good Fit for This Trial?
Adults over 18 with Stage III unresectable Non-Small Cell Lung Cancer (NSCLC) who haven't worsened after platinum-based chemoradiation. They must have normal organ function, no history of certain autoimmune diseases or other cancers within the last 5 years, and not be on immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Durvalumab in combination with Oleclumab or Monalizumab, or Durvalumab with placebo, administered in 28-day cycles for up to 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival assessments
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Monalizumab
- Oleclumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology