ACTRN12610000571077招募中2 期
A Phase I-II Clinical Study to evaluate the effect of Nimotuzumab (TheraCIM h-R3) in Combination with External Radiotherapy on overall survival in patients with Stage IIB, III or IV Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 128
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.Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- •2.Patients must be suitable for palliative radiation therapy to lung disease as per institutional standards.
- •3.Stage IIB, III or IV (patients off steroids for a minimum of 4 weeks with no evidence of symptomatic neurologic progression with treated, stable brain metastases are eligible).
- •4.Patients may be symptomatic or asymptomatic from disease.
- •5.Age >18 years.
- •6.Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1-2.
- •7.Patients who received previous chemotherapy are allowed.
- •8.Haemoglobin >9g/dL (blood transfusion to increase Hb level is acceptable).
- •9.Stage II/III patients must be considered unsuitable for radical (standard full dose curative intent) radiation/chemoradiation in the opinion of either the radiotherapist or medical oncologist (with reasons documented).
- •10.Patients must have measurable disease in the planned radiation field.
- •11.Women of child-bearing potential and men must agree to use adequate contraception.
- •12.Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Patients receiving any other investigational agents.
- •2. Previous treatment with anti-Epidermal growth factor receptor (EGF-R) drug(s) (e.g. Tarceva, Erbitux, etc).
- •3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
- •4. Previously treated with thoracic radiotherapy at any time after the diagnosis.
- •5. Prior chemotherapy within 4 weeks of enrolment.
- •6. Lesions not suitable for radiotherapy.
- •7. Patients with known sero positive Human immunodeficiency virus (HIV).
- •8. Patients with uncontrolled hypercalcemia.
- •9. Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids.
- •10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
- •11. Pregnant or breast-feeding women.
- •12. Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; patients with other prior malignancies are eligible providing prior malignancy cannot be clinically confused with the diagnosis of NSCLC in the opinion of the treating oncologist; in particular, there should be no evidence of current disease activity with respect to the prior malignancy.
- •13. Life expectancy of less than 8 weeks.
研究者
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