A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF DURVALUMAB FOR THE TREATMENT OF STAGE II-III NSCLC PATIENTS WITH MINIMAL RESIDUAL DISEASE FOLLOWING SURGERY AND CURATIVE INTENT THERAPY (MERMAID-2)

AstraZeneca AB,0 个研究点目标入组 0 人开始时间: 2020年11月9日最近更新: 2023年11月13日

适应症

试验速览

阶段: 未知
状态: 已完成
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
•1Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in this protocol.
•2Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.
•- ICF1 must be signed and dated prior to initiation of the first screening and surveillance activities outlined in Table 1.
•- ICF2a must be signed and dated prior to initiation of the second screening activities and randomization outlined in Table 2.
•- ICF2b must be signed and dated prior to initiation of the study-specific observation period and procedures outlined in Table 4.
•3Provision of signed and dated written optional genetic informed consent prior to collection of the optional sample for genetic analysis. This consent should be signed at the time of second screening. This optional sample and analyses are separate from the mandatory genetic testing consent included in ICF1.
•5.1.1Inclusion criteria assessed during the first screening period
•The following criteria must have been met at the time of surgery or at the time of the curative intent therapy (first screening):
•4Age ≥18 years at the time of screening (ICF1).
•5Male and/or female.
•Type of subject and disease characteristics
•6Histologically confirmed NSCLC with resectable stage II-III disease (according to IASLC Staging Manual in Thoracic Oncology v8.0) who have undergone curative intent therapy (complete resection of the primary tumor ± neoadjuvant and/or adjuvant therapy) per SoC.
•Select stage IIIB (ie, T3N2 or T4N2) patients will be eligible, provided they are upstaged to T3N2 or T4N2 based on confirmed pathology after surgery. Patients who are staged as T3N2 or T4N2 prior to surgery are not eligible.
•7A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal glands) along with brain MRI (preferred) or brain CT with IV contrast must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (computerized tomography) within the 6 weeks prior to surgery in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. If the positron emission tomography (PET) scan was not performed, or data from a PET is not available, patients may still be enrolled into the study provided appropriate imaging (CT/MRI) is performed prior to randomization.
•8Complete resection of the primary NSCLC is mandatory. Invasive (pre-operative or intra-operative) exploration of hilar and mediastinal lymph nodes must have been performed to confirm primary tumor nodal status (prior to or after surgery). Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATs) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy or pneumonectomy. Patients undergoing wedge resection are not eligible for this study.
•Note: Where a resection has been extended by means of a wedge resection of an adjacent lobe to ensure complete resection of a tumor at or crossing a fissure between lobes, this is acceptable if surgical margins are clear of disease. Where the resection of a second tumo

排除标准

•Exclusion criteria
•These exclusion criteria must be checked during first and/or second screening periods, as summarized in Table 6. If a patient meets an exclusion criterion at one of these timepoints, the patient is ineligible to continue in the study.
•Diagnostic assessments
•1EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a well-validated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable.
•2Mixed small cell and NSCLC histology.
•3Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
•4Baseline imaging demonstrating unequivocal evidence of RECIST 1.1-defined disease recurrence or evidence of clinical recurrence outside of imaging prior to randomization. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
•Medical conditions
•5History of allogeneic organ or bone marrow transplantation.
•6Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection
•7Active 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 [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
•Patients with vitiligo or alopecia
•Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
•Any chronic skin condition that does not require systemic therapy
•Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
•Patients with celiac disease controlled by diet alone
•8Uncontrolled 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.
•9History of another primary malignancy except for
•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
•Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•Adequately treated carcinoma in situ without evidence of disease
•10History of active primary immunodeficiency
•11Active infection including tuberculosis (clinical evaluation that includes clinical history,

研究者

发起方

AstraZeneca AB,

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