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.
Brief SummaryThis 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.
Detailed DescriptionThis is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during a 96-week surveillance period.
Inclusion and Exclusion Criteria
- 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
- EGFR and/or ALK mutant
- Mixed small cell and NSCLC histology
- History of allogeneic organ or bone marrow transplantation
- History of active primary immunodeficiency
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.