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) - AEGEA

AstraZeneca AB0 个研究点目标入组 800 人开始时间: 2019年3月22日最近更新: 2024年5月6日

研究概览

暂无简介。

•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 patients tumour PD-L1 status
•8. Provision of sufficient tumor biopsy sample for evaluation and confirmation of EGFR and ALK status
•9. Planned surgery to be performed need to include lobectomy, sleeve resection, or bilobectomy
•10. A pre- or post-bronchodilator FEV of 1.0 L and > 40% post-operative predicted value
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 280
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 520

•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 tumor such as mixed small cell and NSCLC histology
•12. Patients who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections
•13. Patients with a documented test result confirming the presence of EGFRm or ALK translocation

发起方