Stereotactic ablative body radiotherapy (SABR) combined with immunotherapy (L19-IL2) versus standard of care in stage IV NSCLC patients, ImmunoSABR: a multicentre, randomised controlled open-label phase II trial

Relinde I. Y. Lieverse*, Evert J. Van Limbergen, Cary J. G. Oberije, Esther G. C. Troost, Sine R. Hadrup, Anne-Marie C. Dingemans, Lizza E. L. Hendriks, Franziska Eckert, Crispin Hiley, Christophe Dooms, Yolande Lievens, Monique C. de Jong, Johan Bussink, Xavier Geets, Vincenzo Valentini, Giuliano Elia, Dario Neri, Charlotte Billiet, Amir Abdollahi, David PasquierPierre Boisselier, Ala Yaromina, Dirk De Ruysscher, Ludwig J. Dubois, Philippe Lambin

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

21 Citations (Web of Science)

Abstract

BackgroundAbout 50% of non-small cell lung cancer (NSCLC) patients have metastatic disease at initial diagnosis, which limits their treatment options and, consequently, the 5-year survival rate (15%). Immune checkpoint inhibitors (ICI), either alone or in combination with chemotherapy, have become standard of care (SOC) for most good performance status patients. However, most patients will not obtain long-term benefit and new treatment strategies are therefore needed. We previously demonstrated clinical safety of the tumour-selective immunocytokine L19-IL2, consisting of the anti-ED-B scFv L19 antibody coupled to IL2, combined with stereotactic ablative radiotherapy (SABR).MethodsThis investigator-initiated, multicentric, randomised controlled open-label phase II clinical trial will test the hypothesis that the combination of SABR and L19-IL2 increases progression free survival (PFS) in patients with limited metastatic NSCLC. One hundred twenty-six patients will be stratified according to their metastatic load (oligo-metastatic:

Original languageEnglish
Article number557
Number of pages10
JournalBMC Cancer
Volume20
Issue number1
DOIs
Publication statusPublished - 15 Jun 2020

Keywords

  • Immunotherapy
  • L19-IL2
  • Anti-PD-L1
  • Anti-PD-1
  • Radiotherapy
  • SABR
  • Phase 2
  • NSCLC
  • Stage IV
  • Multicentre
  • CELL LUNG-CANCER
  • LOCAL CONSOLIDATIVE THERAPY
  • ED-B FIBRONECTIN
  • EXTRA-DOMAIN-B
  • IMMUNOCYTOKINE L19-IL2
  • MAINTENANCE THERAPY
  • RADIATION-THERAPY
  • DOSE-ESCALATION
  • SOLID TUMORS
  • MARKER

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