A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

Inclusion Criteria:

1. Age ≥18 years
2. Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
3. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
4. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
5. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
6. Adequate organ and marrow function
7. Confirmation of a patient's tumour PD-L1 status
8. Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
9. Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Exclusion Criteria:

1. History of allogeneic organ transplantation
2. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
3. History of another primary malignancy
4. History of active primary immunodeficiency
5. Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
6. Deemed unresectable NSCLC by multidisciplinary evaluation
7. Patients who have pre-operative radiotherapy treatment as part of their care plan
8. Patients who have brain metastases or spinal cord compression
9. Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
10. Known allergy or hypersensitivity to any of the study drugs or excipients
11. Existence of more than one primary tumour such as mixed small cell and NSCLC histology
12. Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
13. Patients with a documented test result confirming the presence of EGFRm or ALK translocation