2023-509576-42-00招募中3 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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 41
- 主要终点
- Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).
研究概览
简要总结
To compare the efficacy of durvalumab + chemotherapy administered prior To surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior To surgery followed by placebo post-surgery in terms of EFS.
To compare the activity of durvalumab + chemotherapy administered prior To surgery compared with placebo + chemotherapy administered prior To surgery in terms of pCR.
研究设计
- 分配方式
- Randomized
- 主要目的
- Post-Treatment Follow Up Period
- 盲法
- Double (Investigator, Subject, Analyst, Carer, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value.
- •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 to be performed need to include lobectomy, sleeve resection or bilobectomy.
排除标准
- •History of allogeneic organ transplantation.
- •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 who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections.
- •Patients with a documented test result confirming the presence of EGFRm or ALK translocation.
- •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 preoperative 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.
结局指标
主要结局
Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).
Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).
次要结局
- DFS in the modified resected population.
- mPR (≤10% viable tumour cells in lung primary tumour after complete evaluation in the resected lung cancer specimen).
- OS.
- EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC ≥1%.
- Change from baseline in Patient reported outcomes and time to deterioration.
- Concentration of durvalumab.
- Presence of ADAs for durvalumab.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (41)
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