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)

AstraZeneca AB0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: AstraZeneca AB

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Informed consent
•1.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
•3. Provision of signed and dated written ICF prior to collection of sample for genetic analysis.
•4. Age =18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
•Type of patient and disease characteristics
•5. Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease (according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).
•i).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.
•ii).Nodal status should be investigated with whole body 18F-fluoro-deoxyglucose positron emission tomography (FDG-PET), plus contrast-enhanced computed tomography (CT) in addition to or in combination with PET before surgery. If 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 nodal status should be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy. (preoperative mediastinal lymph node staging).
•iii).Mandatory brain magnetic resonance imaging (MRI; preferred) with IV contrast or brain CT with IV contrast at the time of staging.
•6. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrolment.
•7. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by CT or MRI scan must be performed within 28 days prior to randomization.
•8. 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.
•9. Adequate organ and marrow function as defined below:
•i).Hemoglobin =9.0 g/dL
•ii).Absolute neutrophil count =1.5 × 109/L
•iii).Platelet count =100 × 109/L
•iv).Serum bilirubin =1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
•v).ALT and AST =2.5 × ULN
•vi).Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL >40 mL/min as determined by Cockcroft-Gault (using actual body WT)
•Creatinine CL is equal to WT (kg) × (140-Age) (mL/min) 72 × serum creatinine (mg/dL)
•Creatinine CL is equal to WT (kg) × (140-Age) × 0.85(mL/min) 72 × serum creatinine (mg/dL)
•10. Must have a life expectancy of at least 12 weeks.
•11. Body WT >30 kg.
•12. Male and/or female.
•Tumor sample requirements:
•13. Confirmation of a patient’s tumor PD-L1 status must occur

排除标准

•Medical conditions
•1. History of allogeneic organ transplantation.
•2. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [eg, granulomatosis with polyangiitis, Graves’ disease, rheumatoid
•arthritis, hypophysitis, or uveitis]).
•The following are exceptions to this criterion:
•i).Patients with vitiligo or alopecia.
•ii).Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
•iii).hormone replacement.
•iv).Any chronic skin condition that does not require systemic therapy.
•v).Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
•vi).Patients with celiac disease controlled by diet alone.
•3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
•4. History of another primary malignancy, except for the following:
•i).Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence
•ii).Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•iii).Adequately treated carcinoma in situ without evidence of disease
•5. History of active primary immunodeficiency
•6. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
•7. Deemed unresectable NSCLC by multidisciplinary evaluation that must include a thoracic surgeon who perform lung cancer surgery as a significant part of their practice
•8. Patients who have pre operative radiotherapy treatment as part of their care plan
•9 Patients who have brain metastases or spinal cord compression. All patients will have an MRI (preferred) or high quality CT with IV contrast of the brain, prior to study entry.
•10. Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
•11. Mean QT interval corrected for heart rate using Fridericias formula (QTcF) =470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
•12. Mixed small cell and NSCLC histology.
•13. Known allergy or hypersensitivity to any of the stud

研究者

发起方

AstraZeneca AB

相似试验

进行中（未招募）

1 期

A Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Non-small Cell Lung CancerPatients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIBeither squamous or non-squamous)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-002997-29-BGAstraZeneca AB800

进行中（未招募）

1 期

A Study of Durvalumab Before and After Surgery for Patients with Operable Non-Small Cell Lung Cancer.Patients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIBeither squamous or non-squamous)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-002997-29-NLAstraZeneca AB800

进行中（未招募）

1 期

EUCTR2018-002997-29-FRAstraZeneca AB800

进行中（未招募）

1 期

EUCTR2018-002997-29-DEAstraZeneca AB800

进行中（未招募）

1 期

A Study of Durvalumab Before and After Surgery for Patients with Operable Non-small Cell Lung Cancer

EUCTR2018-002997-29-ATAstraZeneca AB800