ACTRN12609000062224终止3 期
109493: A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC (non-small cell lung cancer).
- •2. The patient's tumor shows expression of MAGE-A3 gene
- •3. The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy.
- •4. The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI (magnetic resonance imaging) of the brain.
- •Other examinations should be performed as clinically indicated.
- •5. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of randomization.
- •6. Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
排除标准
- •1. The primary tumor was removed by segmentectomy or wedge resection.
- •2. The patient shows any evidence of residual tumor after surgery.
- •3. The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:
- •- For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years),
- •- Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.
- •4. The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
- •5. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- •6. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- •7. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
- •Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
- •8. The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
- •9. The patient needs home oxygenation.
- •10. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
研究者
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