A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.
Overview
Overview
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Key Inclusion Criteria
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.
- Age ≥18 years at the time of screening (ICF1);
- Histologically confirmed NSCLC with resectable stage II-III disease
- Complete resection of the primary NSCLC
Key Exclusion Criteria
Key Exclusion Criteria
- EGFR and/or ALK mutant
- Mixed small cell and NSCLC histology
- History of allogeneic organ or bone marrow transplantation
- History of active primary immunodeficiency
Learn More
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Phase III
Principal Investigator(s)
Vikas Dembla, MD
Sponsor(s)
AstraZeneca
Contact Us
Contact Us
For more information about this study, please contact Clinical Research at
864-560-6812