Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03705403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2018-06-27
Brief Title:
IMMUNOtherapy and Stereotactic ABlative Radiotherapy IMMUNOSABR a Phase II Study
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Stereotactic Ablative Body Radiotherapy SABR Combined With Immunotherapy L19-IL2 in Stage IV NSCLC Patients ImmunoSABR a Multicentre Randomised Controlled Open-label Phase II Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMUNOSABR2
Brief 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
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
Detailed Description:
IMMUNOSABR will include 126 patients In this single-stage controlled randomised open-label phase II trial we aim to demonstrate an absolute increase in progression-free survival primary endpoint PFS will be determined as the time between randomisation and disease progression according to RECIST 11 death due to any cause or last patient contact alive and progression-free Patients will be randomized between control no immunocytokine and experimental arms with immunocytokine L19-IL2 in a 11 ratio The accrual period will be 29 months or 241 years and the minimum follow-up will be 18 months or 15 years making the total study duration 47 months Comparison between control and experimental arms will be made using the Log-Rank statistic This test for superiority will be one-sided with the desired type I error of 010 and power of 090
Patients enrolled in the trial will be randomised into the control arm C-arm or experimental arm E-arm
C-arm Standard of Care SOC according to the local and national guidelines wait and see or surgery andor chemotherapy andor standard symptomatic radiotherapy andor SABR oligometastatic disease
E-arm SABR oligometastatic disease or radiotherapy diffuse disease L19-IL2 up to 6 cycles aPDL1 if SOC
The expected 15-year PFS is 15 in the C-arm and 35 in the E-arm A sample size of 116 patients 58 patients per treatment arm is needed to show this difference of 20 in PFS using a logrank test with a two-sided alpha of 005 and power of 85 Patients will be evenly divided over the two arms Assuming a drop-out rate of 10 a total of 126 patients 63 per arm need to be included
Primary objective The main objective of the trial is to test if the activity of the combination of SABR and L19-IL2 in patients with metastatic NSCLC will result in improved progression-free survival PFS compared to the SOC
Secondary Objectives
Assessment of the PFS of the patient cohort at 5 years after randomisation
Assessment of the overall survival of the patient cohort at 5 years after randomisation
To assess the toxicity of this treatment schedule
To assess Quality of Life QoL
To assess the occurrence of an Out of Field Radio-Immune OFRI response abscopal effect using imaging
To assess the occurrence of an In Field Radio-Immune IFRI response using imaging
To perform correlative biomarker studies related to treatment response
Exploratory endpoints
Correlative biomarker studies
Tumour tissue eg EDB expression non-synonymous mutations immune monitoring
Blood eg EDB expression cfDNA and immune monitoring
Radiomics on CT and if available MRI
Faeces diversity in microbiota
iRECIST
Tumour grow kinetics
Patients enrolled in the trial will be randomised into the control arm C-arm or experimental arm E-arm
C-arm Standard of Care SOC according to the local and national guidelines wait and see or surgery andor chemotherapy andor standard symptomatic radiotherapy andor SABR oligometastatic disease
E-arm SABR oligometastatic disease or radiotherapy diffuse disease L19-IL2 up to 6 cycles aPDL1 if SOC
The expected 15-year PFS is 15 in the C-arm and 35 in the E-arm A sample size of 116 patients 58 patients per treatment arm is needed to show this difference of 20 in PFS using a logrank test with a two-sided alpha of 005 and power of 85 Patients will be evenly divided over the two arms Assuming a drop-out rate of 10 a total of 126 patients 63 per arm need to be included
Primary objective The main objective of the trial is to test if the activity of the combination of SABR and L19-IL2 in patients with metastatic NSCLC will result in improved progression-free survival PFS compared to the SOC
Secondary Objectives
Assessment of the PFS of the patient cohort at 5 years after randomisation
Assessment of the overall survival of the patient cohort at 5 years after randomisation
To assess the toxicity of this treatment schedule
To assess Quality of Life QoL
To assess the occurrence of an Out of Field Radio-Immune OFRI response abscopal effect using imaging
To assess the occurrence of an In Field Radio-Immune IFRI response using imaging
To perform correlative biomarker studies related to treatment response
Exploratory endpoints
Correlative biomarker studies
Tumour tissue eg EDB expression non-synonymous mutations immune monitoring
Blood eg EDB expression cfDNA and immune monitoring
Radiomics on CT and if available MRI
Faeces diversity in microbiota
iRECIST
Tumour grow kinetics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None