drugset / Trial / NCT03705403
IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study
Phase 2
Terminated
88 enrolled
Maastricht University Medical Center
Academisch Ziekenhuis Maastricht · collabCatholic University of the Sacred Heart · collabCentre Oscar Lambret · collabCliniques universitaires Saint-Luc- Université Catholique de Louvain · collabErasmus Medical Center · collabGasthuis Zusters Antwerpen · collabHeidelberg University · collabInstitut du Cancer de Montpellier - Val d'Aurelle · collabKU Leuven · collabThe Netherlands Cancer Institute · collabUniversity College, London · collabUniversity Ghent · collabUniversity Hospital Dresden · collabUniversity Hospital Tuebingen · collabUniversity Medical Center Nijmegen · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This will be a phase II trial testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC). The trial consists of one cohort with two arms; C-arm and an E-arm. Patients with oligometastatic disease will receive SABR to minimal 1 and max all metastatic sites (max 5 sites irradiated) and patients with diffuse metastatic lesions (6 to max 10) will receive radiotherapy to max 5 sites. In the experimental arm, immunotherapy will be given after irradiation.
Timeline
- Start
- 2019-04-04
- Primary completion
- 2025-01-06
- Completion
- 2025-01-06
Publications
- Olivo Pimentel V, Marcus D, van der Wiel AM, Lieuwes NG, Biemans R, Lieverse RI, Neri D, Theys J, Yaromina A, Dubois LJ, Lambin P. Releasing the brakes of tumor immunity with anti-PD-L1 and pushing its accelerator with L19-IL2 cures poorly immunogenic tumors when combined with radiotherapy. J Immunother Cancer. 2021 Mar;9(3):e001764. doi: 10.1136/jitc-2020-001764.
- Lieverse RIY, Van Limbergen EJ, Oberije CJG, Troost EGC, Hadrup SR, Dingemans AC, Hendriks LEL, Eckert F, Hiley C, Dooms C, Lievens Y, de Jong MC, Bussink J, Geets X, Valentini V, Elia G, Neri D, Billiet C, Abdollahi A, Pasquier D, Boisselier P, Yaromina A, De Ruysscher D, Dubois LJ, Lambin P. 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. BMC Cancer. 2020 Jun 15;20(1):557. doi: 10.1186/s12885-020-07055-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darleukin | Protein / enzyme biologic | — | — |