Cancer types
  • Lung
Title of study
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer
Version Number
Approval Date 
2, 14 May 2019
Short Title
ImmunoSABR
Study site
Principle Investigator
L. Hendriks (MUMC)
Investigator Maastro
D. DeRuysscher
Sponsor
Maastricht University
Trial registry
Objectives 

The main objective of the trial is to test if the combination of (SAB)R and the immunocytokineL19-IL2 has clinical meaningfulactivity in patients with limited metastatic non-small cell lung cancer (NSCLC): (≤10 sites, WHO 0-1). The expected activity is a systemic immune response preventing disease progression and resulting in an improvement of progression-freesurvival (PFS)at 1.5 year.

Primary Endpoint 

Progression Free Survival (PFS) at 1.5 years afterrandomisation.

Secondary Endpoints 

-PFS; – Overall survival; -Toxicity(CTCAEv4); -Quality of Life (EORTC QLQ C30 v3.0, QLQ LC13 and EQ5D); -The occurrenceof OFRI / the abscopaleffect using imaging, based on RECIST criteria; -The occurrence of an IFRIresponse, based on RECIST criteria Exploratory endpoints: -Correlative biomarker studies: Tumour tissue: e.g EDB expression, non-synonymous mutations, immune monitoring, Blood: e.g. EDB expression, cfDNA, and immune monitoring Radiomics on CT and if available MRI Faeces: diversity in microbiota.