CTRI/2023/06/054174尚未招募3 期
Phase III randomized study of low dose bevacizumab versus standard dose bevacizumab in non-squamous NSCLC-LoBev. - LoBev
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- •1. Subjects must have non-squamous NSCLC warranting palliative chemotherapy in the first line setting. Patients who have received one or two cycles of palliative systemic chemotherapy, while awaiting the results of molecular driver mutation testing will be considered eligible for this study.
- •2. Aged = 18 years
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •4. Normal organ and marrow functions as per the institute protocols
- •5. Patients with human immunodeficiency virus (HIV)infection are potentially eligible, as long as they have a CD4 count > 200 cells/mm3, are on concurrent highly active antiretroviral therapy (HAART), and have the absence of active AIDS defining conditions
- •6. Unable to receive, have a contraindication to, or there is no indication for immune checkpoint inhibitors or molecularly targeted therapies in the first line setting
- •7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments
- •8. Ability to understand and the willingness to sign a written informed consent document
排除标准
- •1. Subjects who are receiving any other investigational agents
- •2. Current use of immunosuppressive medication, EXCEPT for the following:
- •a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
- •b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent
- •c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •d. Steroids for raised intracranial pressure due to the disease itself
- •e. Steroid use for avoidance or treatment of emesis.
- •3. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent, including
- •a. Clinically significant (i.e., active)cardiovascular disease, cerebrovascular accident/stroke ( <3 months prior to enrollment), myocardial infarction ( <3 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- •b. Patients with severe renal and liver dysfunction Child Pugh B or C
- •4. Prior organ transplantation including allogeneic stem-cell transplantation
- •5. Known severe hypersensitivity to bevacizumab or any of the excipients of this product
- •6. Patients with Mutation positive Lung cancer receiving at least one line of chemotherapy with progression disease.
- •7.. Pregnant and lactating women are excluded from this study.
- •8. History of:
- •a.Recent (within preceding 3 months) stroke or cerebrovascular accident
- •b.Documented hemorrhagic diathesis or coagulopathy
- •c.Active untreated arterial thromboembolic event
- •d.Significant, i.e., grade 2 or higher hemoptysis ( > ½ teaspoon bright red blood per event) attributable to the lung primary
研究者
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