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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:3/28/2019
Start Date:December 6, 2018
End Date:September 8, 2025
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

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 major
pathological response.


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
We found this trial at
24
sites
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Charleston, South Carolina 29412
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Salisbury, North Carolina 28144
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San Salvador de Jujuy,
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