Multicentre, randomised, phase II study examining the activity of L19-IL2 immunotherapy and Stereotactic ABlative Radiotherapy in metastatic non-small cell lung cancer: ImmunoSABR

Maastricht University0 sites88 target enrollmentJune 7, 2020

Overview

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32539805/ protocol (added 17/06/2020)

Registry

who.int

Start Date

June 7, 2020

End Date

January 31, 2025

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Oligometastatic disease participants:
•1\. Histological/cytological confirmed limited metastatic adult NSCLC patients, regardless of the PD\-L1 status
•2\. \=5 metastatic lesions and \=2 brain lesions with a total cumulative diameter of 5 cm
•3\. In patients with 2 lung tumours, it can be unclear if the patient has 2 concurrent primary tumours or a primary lung tumour with 1 metastasis. Whether the patient has an M1 disease or not will be at the discretion of the local multidisciplinary tumour board.
•4\. Prior cancer treatments must have been discontinued for \=4 weeks before randomisation. In case of maintenance chemotherapy, this therapy will only be started after the end of the L19\-IL2 treatment or only in case of Anti\-PD(L)1 treatment, during L19\-IL2 therapy.
•Poly\-metastatic disease participants:
•1\. Histological/cytological confirmed limited metastatic adult NSCLC patients, regardless of the PD\-L1 status
•2\. Between 6 and 10 metastatic lesions, inclusive, and \=2 brain lesion with a total cumulative diameter of 5cm
•3\. Last administration of chemo and/or immunotherapy (given as a first or second\-line standard of care treatment) \=4 weeks before randomisation. In case of maintenance chemotherapy, this therapy will only be started after the end of the L19\-IL2 treatment or only in case of Anti\-PD(L)1 treatment, during L19\-IL2 therapy.
•All participants:

•1\. \=10 metastatic lesions
•2\. \=2 brain metastatic lesions
•3\. 2 brain metastases with a cumulative diameter \=5 cm
•4\. Patients with non\-infectious pneumonitis, uncontrolled thyroid disease, pleuritis, pericarditis and peritonitis carcinomatosis
•5\. Received live vaccines \=30 days prior to enrolment
•6\. Already actively participating in another study
•7\. Requiring simultaneous radiation on the primary tumour and metastatic lesion(s). For these patients, it might be an option to treat the primary tumour first, although this is not mandatory for this study.
•8\. Whole\-brain radiotherapy (WBRT) is not allowed, although it is accepted when given at \=4 weeks prior to randomisation or after the treatment period. Patients with stable brain metastases are not excluded.
•9\. Previous radiotherapy to an area that would be re\-treated by (SAB)R, resulting in overlap of the high dose areas.
•10\. Maintenance therapy with Anti\-PD(L)1 treatment combined with chemotherapy during treatment ((SAB)R and L19\-IL2 cycles)