K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- Radiation: Stereotactic body radiation therapy (SBRT)Drug: Temporary Stopping
- Registration Number
- NCT06127940
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy + sotorasib Stereotactic body radiation therapy (SBRT) 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. Radiotherapy + sotorasib Temporary Stopping 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.
- Primary Outcome Measures
Name Time Method Safety - Grade 3 - 5 toxicity attributed to SBRT 6 months post SBRT The number of patients presenting with grade 3-5 toxicity (attributed to SBRT) within 6 months post SBRT.
- Secondary Outcome Measures
Name Time Method Progression free survival 1 year The number of patients who have progressed or died during the first 12 months post start of sotorasib (estimated using the KM-method).
Overall toxicity related to sotorasib 1 year No and percentage of patients suffering toxicity attributed to sotorasib (early toxic effects presenting within 3 months of finalization of SBRT vs late toxic effects presenting after more than 3 months post completion of SBRT).
Duration of response 1 year The time between the date of first observation of CR or PR and the date of documented progressive disease for evaluable subjects. In all other situations, observations will be censored, or analysis only performed on those subjects who achieve a response.
Overall toxicity related to SBRT 1 year No and percentage of patients suffering toxicity attributed to SBRT (early toxic effects presenting within 3 months of finalization of SBRT vs late toxic effects presenting after more than 3 months post completion of SBRT).
Overall survival 1 year The number of patients who have died during the first 12 months post start of sotorasib (estimated using the KM-method).
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Solna, Sweden