A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Hongqing Zhuang, Doctor
- 电话号码：010-82264931
- 邮箱：hongqingzhuang@163.com
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100191
- Peking University Third Hospital
-
接触：
- Hongqing Zhuang, Doctor
- 邮箱：hongqingzhuang@163.com
-
首席研究员：
- Hongqing Zhuang, Doctor
-
Beijing、Beijing、中国、100142
- Beijing Cancer Hospital
-
接触：
- Huiming Yu, Doctor
-
首席研究员：
- Huiming Yu, Doctor
-
-
Shanghai
-
Shanghai、Shanghai、中国、200040
- Huashan Hospital Fudan University
-
接触：
- Enmin Wang, Doctor
-
首席研究员：
- Enmin Wang, Doctor
-
-
Tianjin
-
Tianjin、Tianjin、中国、300060
- Tianjin Medical University Cancer Institute and Hospital
-
接触：
- Zhiyong Yuan, Doctor
-
首席研究员：
- Zhiyong Yuan, Doctor
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
2. Histologically or pathologically confirmed advanced non-small cell lung cancer.
3. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
4. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
5. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and Signed an informed consent form.
Exclusion Criteria:
1. Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug.
3. Has severe hypersensitivity reaction to other monoclonal antibodies. 4. Has diagnosed and/or treated additional malignancy within 5 years prior to the first administration.Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
5. Has any active autoimmune disease or a history of autoimmune disease. 6. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
7. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
8. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
9. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
11. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TQB2450+SBRT
SBRT three days before TQB2450.
|
TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Give according to the location of the lesion and clinical condition.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS)
大体时间：Baseline up to 96 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
|
Baseline up to 96 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate (ORR)
大体时间：Baseline up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR).
|
Baseline up to 96 weeks
|
|
Overall survival (OS)
大体时间：Baseline up to 96 weeks
|
OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
|
Baseline up to 96 weeks
|
|
Disease control rate（DCR）
大体时间：Baseline up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
|
Baseline up to 96 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.