The IMMUNOSABR project is divided into six Work Packages (WPs), designed to quickly and efficiently obtain clinical proof of concept in a randomised Phase II study for patients with limited metastatic NSCLC (Figure 1). In WP1, we will set-up a professional clinical study management structure in which the regulatory approvals for each centre will be coordinated. In addition, this WP will ensure that the clinical trial teams are updated with the latest international GCP training. WP2 has been designed to produce the GMP grade L19-IL2 for clinical use. Within WP3 the Phase II trial (NCT02735850) will be conducted which will mainly assess the clinical efficacy for the treatment strategy. WP4 will focus on developing highly innovative CT- based radiomics and PET-hypoxia imaging patient stratification
tools, while WP5 will be the immunological monitoring WP that will identify biomarkers for patient selection and early response assessment, and to define the biomarker strategy for a future phase III trial. WP6 is designed to coordinate the IMMUNOSABR consortium and ensures that the expected impact of the project will be reached. WP6 will conduct dissemination and exploitation activities including a full-fledged business development strategy for the further development of L19-IL2 as a commercial drug, and translate the bi-modal treatment strategy towards clinical implementation.
Important milestones for IMMUNOSABR:
- Progression-free survival, overall survival, local control rate, toxicity, quality of life.
- Biomarkers for L19-IL2 (imaging and blood-based).
- Effective dissemination and exploitation (business development) strategy for further development of L19-IL2 for limited metastatic disease from solid tumours (i.e. NSCLC)