ImmunoSABR

Key outcome parameters

Intervention

SABR en L19-IL2 immunotherapy

Key inclusion criteria

Inclusion criteria for Oligometastatic disease (max 5 metastases) or Poly-metastatic disease (6-10 metastases) are different.

Oligometastatic disease

• Histological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status
• Maximum of 5 metastatic lesions, maximum two brain lesion with a total cumulative diameter of 5cm is allowed.
• Prior cancer treatments are allowed but must be discontinued for at least 4 weeks before randomisation.
• WHO performance status 0-1

Poly-metastatic disease

• Histological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status.
• A minimum of 6 and maximum of 10 metastatic lesions, maximum two brain lesion with a total cumulative diameter of 5cm is allowed.
• At least one measurable lesion (according to RECIST 1.1) that has no overlap with the PTV of the lesion subjected to radiotherapy.
• Patient inclusion is allowed from 4 weeks to 8 weeks following the last chemo- and/or immunotherapy infusion (first line or second line).
• WHO performance status 0-1

Key exclusion criteria

Exclusion criteria:

• More than 10 metastatic lesions.
• More than 2 brain metastatic lesions
• 2 brain metastases with a cumulative diameter larger than 5 cm
• Patients with pleuritis, pericarditis and peritonitis carcinomatosis
• Patients who need simultaneous radiation on the primary tumour and metastatic lesion(s). For these patients it might be an option to irradiate the primary tumour first.
• Patients with progressive disease following first line or second line chemo- and/or immunotherap