Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
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.
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
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
- EGFR and/or ALK mutant
- Mixed small cell and NSCLC histology
- History of allogeneic organ or bone marrow transplantation
- History of active primary immunodeficiency
To learn more, visit ClinicalTrials.Gov
Vikas Dembla, MD