Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604470
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2020-10-13
Brief Title:
Trial-specific Patient Decision Aid tPDA of the ImmunoSABR Phase 2
Sponsor:
Maastricht University
Organization:
Maastricht University
Study Overview
Official Title:
Trial-specific Patient Decision Aid tPDA of the ImmunoSABR Phase 2
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
I-SABR2_PDA
Brief Summary:
This is a trial-specific NCT03705403 decision aid tPDA for stage IV NSCLC patients that might want to participate
We want to investigate if a tPDA would be significantly helpful for these patients in making a decision
ImmunoSABR has a complex study design we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together text video questions pictures timelines etc
We want to investigate if a tPDA would be significantly helpful for these patients in making a decision
ImmunoSABR has a complex study design we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together text video questions pictures timelines etc
Detailed Description:
A lung cancer patient might want to take part in the ImmunoSABR phase 2 trial NCT03705403 Before they can decide it is important that the patients understand why the research is being done and what it would involve for them
This tPDA will give information about this trial via text small movies quiz and preferences In the end the patient will receive an overview of their choices
Detailed Description ImmunoSABR
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
This tPDA will give information about this trial via text small movies quiz and preferences In the end the patient will receive an overview of their choices
Detailed Description ImmunoSABR
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
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