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

Overview

About this study

The purpose of this study is to assess 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Age ≥ 18 years old.
  • Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC. Patients should have resectable (Stage IIA to select [i.e., N2] Stage IIIB) disease (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016) and be candidate for lobectomy, sleeve resection, or bilobectomy at the time of screening.
    • At screening, complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice.
    • T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm); any other reason for T4 (e.g., adherent to any of the following structures: diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina) will be considered ineligible.
    • Nodal status should be investigated with whole body 18F-fluoro-deoxyglucose positron emission tomography (FDG-PET), plus contrast-enhanced computed tomography (CT). If positron emission tomography (PET)/CT scan is positive in the mediastinum, or if scan is negative but there is T > 3 cm, central tumor, or clinical N1 (cN1), then it is recommended that nodal status be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy (preoperative mediastinal lymph node staging) for more details.
    • Mandatory brain magnetic resonance imaging (MRI; preferred) with IV contrast or brain CT with IV contrast at the time of staging.
  • 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.
  • Patients with a documented test result confirming the presence of an EGFRm or ALK translocation.

Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Panayiotis Savvides, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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