For Healthcare Professionals

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


About the study

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Non-Small Cell Lung Cancer

Age (in years)

18 - 120


Phase 3

Participants needed


Est. Completion Date

Sep 11, 2028

Treatment type



AstraZeneca identifier


Study number


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