EUCTR2018-002997-29-BG进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 patient's tumour PD-L1 status
- •8. Provision of sufficient tumour 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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 195
排除标准
- •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 preoperative 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
- •11. Existence of more than one primary tumour 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.
研究者
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