NCT04306926Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
- •Histologically or pathologically confirmed advanced non-small cell lung cancer.
- •Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
- •Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
- •Adequate organ system function.
- •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.
排除标准
- •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.
- •Has severe hypersensitivity reaction to other monoclonal antibodies.
- •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.
- •Has any active autoimmune disease or a history of autoimmune disease.
- •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.
- •(Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
- •Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
- •Has any severe and/or uncontrolled disease.
- •Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
- •According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB2450+SBRT
Experimental
SBRT three days before TQB2450.
干预措施: TQB2450 (Drug)
TQB2450+SBRT
Experimental
SBRT three days before TQB2450.
干预措施: SBRT (Radiation)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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.
次要结局
- Objective response rate (ORR)(Baseline up to 96 weeks)
- Overall survival (OS)(Baseline up to 96 weeks)
- Disease control rate（DCR）(Baseline up to 96 weeks)
研究者
研究点 (4)
Loading locations...
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