Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-22
Brief Title:
Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free
Sponsor:
Fundación GECP
Organization:
Fundación GECP
Study Overview
Official Title:
A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIBN2 Previously Resected R0 Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ARIAN
Brief Summary:
Open-label phase III randomized stratified PDL1- vs PDL1 3 arms multicenter clinical trial
129 resected patients 43 per arm with stage from IB to IIIA and IIIB N2 non-small cell lung cancer that do not achieve pathologic complete response pCR after neoadjuvant treatment
This clinical trial has 3 arms of treatment ARM 1 Observation 10 months ARM 2 treatment with immunotherapy Zimberelimab for 13 cycles and ARM 3 treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles
The primary objective is to evaluate the disease-free survival DFS defined as the length of time from randomization to the earliest event defined as disease recurrence any new lung cancer even in the opposite lung or death from any cause at any known point in time
Patient accrual is expected to be completed within 2 years treatment is planned to extend during 1 years and the patients will be followed up for 2 years The study will end once survival follow-up has concluded
129 resected patients 43 per arm with stage from IB to IIIA and IIIB N2 non-small cell lung cancer that do not achieve pathologic complete response pCR after neoadjuvant treatment
This clinical trial has 3 arms of treatment ARM 1 Observation 10 months ARM 2 treatment with immunotherapy Zimberelimab for 13 cycles and ARM 3 treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles
The primary objective is to evaluate the disease-free survival DFS defined as the length of time from randomization to the earliest event defined as disease recurrence any new lung cancer even in the opposite lung or death from any cause at any known point in time
Patient accrual is expected to be completed within 2 years treatment is planned to extend during 1 years and the patients will be followed up for 2 years The study will end once survival follow-up has concluded
Detailed Description:
This is an open-label phase II randomized stratified PDL1- vs PDL1 3 arms multicenter clinical trial
Patients stage IB to IIIA-IIIB T3N2 after surgical resection if they did not achieve a pathological com-plete response pCR will be randomized 111 to
ARM 1 Observational Arm for 10 months
ARM 2 Immunotherapy Zimberelimab treatment for 13 cycles Q3W
ARM 3 Sacituzumab Govitecan Zimberelimab Q3W for 8 cycles Zimberelimab Q3W for 5 cycles Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy
The primary objective is to evaluate the disease-free survival DFS defined as the length of time from randomization to the earliest event defined as disease recurrence any new lung cancer even in the opposite lung or death from any cause at any known point in time
Disease Free survival DFS The time from random assignment to cancer recurrence or death from any cause
Secondary objectives
Overall survival OS at 12 24 and 36 months after the start of adjuvant treatment
Safety and tolerability of the combination of Sacituzumab Govitecan Zimberelimab according to CTCAE v50
Exploratory objectives
- To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS
The total trial duration will be 7 years approximately Approval-start up 4-6 months Patient accrual is expected to be completed within 2 years One year of treatment and 3 years of follow up and close-out 4-6 months The study will end once survival follow-up has concluded
Patients stage IB to IIIA-IIIB T3N2 after surgical resection if they did not achieve a pathological com-plete response pCR will be randomized 111 to
ARM 1 Observational Arm for 10 months
ARM 2 Immunotherapy Zimberelimab treatment for 13 cycles Q3W
ARM 3 Sacituzumab Govitecan Zimberelimab Q3W for 8 cycles Zimberelimab Q3W for 5 cycles Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy
The primary objective is to evaluate the disease-free survival DFS defined as the length of time from randomization to the earliest event defined as disease recurrence any new lung cancer even in the opposite lung or death from any cause at any known point in time
Disease Free survival DFS The time from random assignment to cancer recurrence or death from any cause
Secondary objectives
Overall survival OS at 12 24 and 36 months after the start of adjuvant treatment
Safety and tolerability of the combination of Sacituzumab Govitecan Zimberelimab according to CTCAE v50
Exploratory objectives
- To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS
The total trial duration will be 7 years approximately Approval-start up 4-6 months Patient accrual is expected to be completed within 2 years One year of treatment and 3 years of follow up and close-out 4-6 months The study will end once survival follow-up has concluded
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