Secondary endpoints
death, NPD, AAEs
DISEASE PROGRESSION, METASTASIS, ADVERSE EVENTS, DISEASE, SECONDARY
Every secondary endpoint will be determined for patients included in the recommended scheme administration (expansion phase):
PFS according to RECIST v1.1 and iRECIST, or death from any cause, whichever occurs first. It will be evaluated at 12 months. Additionally, the median will also be displayed.Long-term safety of the SBRT, atezolizumab, and tiragolumab antibody combination will be evaluated with acute and late adverse events (AAEs) according to CTCAE 5.0.Acute adverse events are adverse events occurring within the first sixth months, and late adverse events are adverse events occurring after the first six months.Overall survival (OS) is defined as the time from inclusion to death from any cause.Overall response rate (ORR) and non-progression rate (NPR) are evaluated from the first two evaluation scanner images carried out at 9 and 18 weeks after time from inclusion (CT-scan forecast before the 3rd and 6th cure) as determined by the investigator according to RECIST v1.1 and iRECIST. Overall response is defined by a partial or complete response. Non-progression is defined by a partial or complete response and a stable disease.Duration of response (DOR) is defined as the time from documentation of a disease complete or partial response to disease progression, defined according to RECIST v1.1 and iRECIST. Non-progression duration (NPD) is defined as the time from documentation of a complete response, partial response, or stable disease to a disease progression, as defined according to RECIST v1.1 and iRECIST.Abscopal effect is evaluated following non-irradiated metastasis volume(s) from scanner images.