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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03800134

Run by

AstraZeneca

People needed

825

Starts

2018-12-06

Expected to finish

2028-09-11

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Newly diagnosed and previously untreated patients with 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 patient's tumour PD-L1 status
• Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
• Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

You may not qualify if…

• 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 and C, 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
• Known allergy or hypersensitivity to any of the study drugs or excipients
• Existence of more than one primary tumour such as mixed small cell and NSCLC histology
• Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
• Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Orange, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Ashland, Kentucky, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Silver Spring, Maryland, United States
• Research Site — Towson, Maryland, United States
• Research Site — Duluth, Minnesota, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Shirley, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Bend, Oregon, United States
• Research Site — Medford, Oregon, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Austin, Texas, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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