IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study

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.

Conditions

• NSCLC Stage IV
• Metastatic Disease

Interventions

DRUG

Darleukin

The product name refers to the molecule structure, in fact, L19-IL2 is a recombinant fusion protein composed of two moieties: L19, a human monoclonal antibody fragment in the single chain Fv (scFv) format, bound via a flexible linker to IL2, the human cytokine Interleukin-2.

RADIATION

Radiation

Radiotherapy

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• University Medical Center Nijmegen

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University Ghent

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Centre Oscar Lambret

  collaborator OTHER

• Gasthuis Zusters Antwerpen

  collaborator OTHER

• University College, London

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University Hospital Dresden

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Institut du Cancer de Montpellier - Val d'Aurelle

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Philippe Lambin, MD, PhD · Maastricht University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-04

Primary Completion

2025-01-06

Completion

2025-01-06

Countries

• Belgium
• France
• Germany
• Italy
• Netherlands
• United Kingdom

Study Locations