K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
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.
• Histological or cytological confirmed advanced NSCLC
• KRASG12C mutation
• Previous at least one line of treatment with immune- or/and chemotherapy or contraindications for immune- and/or chemotherapy.
• Adequate organ function to tolerate sotorasib (see section 6.1 and 6.2 for details)
• 2-5 lesions technically amenable to SBRT with 15 Gy x 3, 10 Gy x 5, or 7-8 Gy x 5.
• Adequate organ function to tolerate SBRT:
• o Fulfilment of dose constraints to adequate organs at risk
• ECOG performance status (PS) 0-1
• FEV1 ≥1 litre (only applicable for lung targets)
• Age ≥ 18 years
⁃ Measurable lesions according to RECIST