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

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: Durvalumab, Placebo, Carboplatin, Cisplatin, Pemetrexed

Countries: United States, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

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 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

Locations (231)

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