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

AstraZeneca KK0 个研究点目标入组 78 人开始时间: 2019年3月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 patients tumour PD-L1 status
•- Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
•- Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

•- 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 and C, 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
•- 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 whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
•- Patients with a documented test result confirming the presence of EGFRm or ALK translocation

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