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临床试验 NCT06953843 针对无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases II期 366 免疫疗法
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临床试验NCT06953843旨在研究治疗，主要针对无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2025年7月9日，计划招募366名患者。该研究由Xinqiao Hospital of Chongqing主导，预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月14日。
简要概括
This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with...显示更多
官方标题
An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer
疾病
无EGFR/ALK突变的IV期非小细胞肺癌 (NSCLC)其他研究标识符
- XQonc-023
NCT编号
实际开始日期
2025-07-09
最近更新发布
2025-07-14
预计完成日期
2027-12-31
计划入组人数
366
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group A | Benmelstobart combined with chemotherapy After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart. |
实验性Group B | Benmelstobart combined with chemotherapy After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart. |
实验性Group C | Benmelstobart combined with chemotherapy After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart. |
实验性Group D | Benmelstobart combined with chemotherapy After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart. |
实验性Group E | Benmelstobart combined with chemotherapy After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment. |
实验性Group F | Benmelstobart combined with Bevacizumab and chemotherapy For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The remission rate of abscopal lesions | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
PFS | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1 | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years |
OS | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival | up to 5 years |
AE | The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Non-small cell lung cancer confirmed by pathological histology.
- More than 3 metastatic lesions.
- No brain metastases or stable lesions.
- Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
- Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
- Age between 18 and 75 years old.
- Assessment by PET-CT (including FDG and FMISO, not mandatory).
- No contraindications to immunotherapy and radiotherapy.
- Signed the informed consent form.
Patients with any of the following criteria are not eligible for enrollment in this study:
- Those with severe dysfunction of important vital organs (heart, liver, kidney).
- Those accompanied by other malignant tumors.
- Uncontrolled heart diseases or myocardial infarction within the past 6 months.
- Those with a history of mental illness.
- Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Xinqiao Hospital of Chongqing研究责任方
Jianguo Sun, 主要研究者, Prof, Xinqiao Hospital of Chongqing
研究中心联系人
联系人: Jianguo Sun, MD, 86-13983155736, [email protected]
1 位于 1 个国家/地区的研究中心
Chongqing Municipality
the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, 联系人, 023-68774490, [email protected]
招募中