IRCT20150303021315N29招募中3 期
A phase III, non-inferiority clinical trial to compare efficacy and safety of Pembrolizumab (produced by CinnaGen Co.) versus Pembrolizumab (Keytruda®, produced by Merck Company) in metastatic Non-Small Cell Lung Cancer (NSCLC) patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 295
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
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Aged 18-75 years old at the time of signing informed consent form
- •2.Have a histologically or cytologically confirmed diagnosis of NSCLC, is stage IV, does not have an EGFR sensitizing (activating) mutation or ALK translocation or ROS1 rearrangement
- •Have measurable disease based on RECIST 1.1 as determined by the site
- •Have a life expectancy of at least 3 months
- •ECOG Performance Status 0 or 1
- •Have adequate organ and marrow function
- •Subject has no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
- •Have provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status. Fine needle aspirates, Endobronchial Ultrasound (EBUS) or cell blocks are not acceptable. Needle or excisional biopsies, or resected tissue is required.
排除标准
- •Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment
- •Is receiving systemic steroid therapy = 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication •corticosteroid use on study for management of ECIs, as pre-medication for the control chemotherapies, and/or a premedication for IV contrast allergies/reactions is allowed •Subjects who are receiving daily steroid replacement therapy serve as an exception to this rule. Daily prednisone at doses of 5-7.5 mg is an example of replacement therapy. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy. •The daily oral administration of 8 milligrams of dexamethasone during visits with concurrent chemotherapy is permitted to prevent chemotherapy-induced nausea and vomiting and pemetrexed-induced cutaneous adverse effects.
- •Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)
- •Major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
- •Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to signing the ICF oSubjects with previously treated brain metastases may participate provided they are clinically stable (neurologically asymptomatic) and have no evidence of new or enlarging brain metastasis by imaging at least 2 weeks after treatment of the brain metastases (e.g., surgery, RT) and are off steroids for at least 3 days prior to the first dose of study medication
- •Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects that require inhaled corticosteroids would not be excluded from the study
- •Has had an allogeneic tissue/solid organ transplant
- •Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV steroids
- •Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain a live virus are permitted
- •Has an active infection
- •Has known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •Has known Hepatitis B or Hepatitis C
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participa
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