Primary Outcome Measures
- Major Pathological Response (mPR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
Secondary Outcome Measures
- Pathological complete response (pCR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
- Overall Survival (OS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
- Event-free survival (EFS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
- Disease-free survival (DFS) [ Time Frame: From date of randomization to 5.5 years after date or resection ]
- To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]
- To assess the PK of durvalumab in blood (through concentration) [ Time Frame: From date of randomization to 2 months after resection ]
- Presence of ADA for durvalumab [ Time Frame: From date of randomization to 3 months after last dose of IP ]
- mPR in PD-L1-TC positive patients [ Time Frame: From screening pathology to an average of 15 weeks after first dose ]
- To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]
- Inclusion Criteria
- Age ≥18 years
- Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
- 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
- Adequate organ and marrow function
- Confirmation of a patients tumour PD-L1 status
- Documented EGFR and ALK status
- Exclusion Criteria
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
- History of another primary malignancy
- History of active primary immunodeficiency
- Active infection including tuberculosis hepatitis B, or human immunodeficiency virus
- Deemed unresectable NSCLC by multidisciplinary evaluation
- Patients who have pre-operative radiotherapy treatment as part of their care plan
- Patients who have brain metastases or spinal cord compression
- Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
- Mixed small cell and NSCLC histology
- Patients who are candidates to undergo only segmentectomies or wedge resections
