K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety - Grade 3 - 5 toxicity attributed to SBRT
研究概览
简要总结
The goal of this interventional study is to learn about the combination of sotorasib and stereotactic radiation therapy (SBRT) in patients with metastatic non-small cell lung cancer (NSCLC) with KRASG12C mutations. The main question it aims to answer is:
• can SBRT be safely delivered in patients treated with sotorasib
Participants will be treated with sotorasib for an 8-week-induction period and if the patient has stable disease or partial response, 1-3 of the remaining lesions will be irradiated with SBRT and sotorasib will then be contiuned after irradiation. The patients will then be followed and evaluated for toxicity to identify if grade 3-5 toxicity attributed to SBRT occurs within 6 months post SBRT. Tumour effects measured according to RECIST v1.1 will also be evaluated.
详细描述
Eligible subjects are those with a diagnosis of advanced KRASG12C mutated NSCLC who have received at least one line of standard medical treatment with immuno(chemo)therapy.
The subjects start with sotorasib and in parallel, 2-5 target lesions which are technically feasible to treat with SBRT, are identified. After 8 weeks of induction treatment of with sotorasib, the subjects are radiologically evaluated and subjects with stable disease (SD) or partial response (PR) on sotorasib will receive SBRT to minimum 1 and maximum 3 of the predefined lesions. Sotorasib is withheld during SBRT and then restarted after SBRT.
Sotorasib will continue until progression or other discontinuation criteria are met. The patients are followed clinically every month during the first 6 months post SBRT and then every 2-3 months. Radiological evaluation is performed every 2 months during the first year.
After the first 10 treated patients, a safety review meeting will be held and a decision whether to include 10 more patients will be performed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy + sotorasib
Sotorasib is administered as an 8-week-introduction treatment and if response on a CT-scan is observed (stable disease or partial response), the patient is treated with stereotactic radiation therapy (SBRT) to 1-3 of the remaining lesions.
干预措施: Stereotactic body radiation therapy (SBRT) (Radiation)
Radiotherapy + sotorasib
Sotorasib is administered as an 8-week-introduction treatment and if response on a CT-scan is observed (stable disease or partial response), the patient is treated with stereotactic radiation therapy (SBRT) to 1-3 of the remaining lesions.
干预措施: Temporary Stopping (Drug)
结局指标
主要结局
Safety - Grade 3 - 5 toxicity attributed to SBRT
时间窗: 6 months post SBRT
The number of patients presenting with grade 3-5 toxicity (attributed to SBRT) within 6 months post SBRT.
次要结局
- Overall toxicity related to sotorasib(1 year)
- Progression free survival(1 year)
- Duration of response(1 year)
- Overall survival(1 year)
- Overall toxicity related to SBRT(1 year)
研究者
Karin Lindberg
Principal investigator
Karolinska University Hospital