Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333678
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer NSCLC
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Randomized Phase II Study of Sotorasib Versus Continued Consolidation Durvalumab in Patients With KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer LANSCLC With Persistent ctDNA Defined Minimal Residual Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease MRD is an effective treatment approach for locally advanced non-small cell lung cancer LA-NSCLC The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab and not switching to sotorasib
Detailed Description:
In the first phase of the randomized trial defined as the Pre-Monitoring Phase patients with LANSCLC with a KRAS G12C mutation who are planned to undergo are undergoing or very recently completed definitive chemoradiation with the plan for durvalumab consolidation are enrolled Chemoradiation treatment and all clinical assessments during the Pre-Monitoring Phase are per standard of care as per institutional standards
Patients who 1 complete chemoradiation 2 have detectable ctDNA post chemoradiation 3 are without evidence of progressive disease on imaging 4 and are planned to start durvalumab consolidation then continue into the Monitoring Phase All other patients are no longer on trial and are taken off study Patients in the Monitoring Phase will have ctDNA measured again early-on during durvalumab consolidation ie cycle 3 of durvlalumab - 2 weeks in conjunction with standard of care imaging Patients with MRD will then continue to the Randomization Phase of trial
In the Randomization Phase patients will be randomized in a 11 fashion to continue standard of care durvalumab group 1 vs switch to sotorasib at 960 mg daily group 2 with the primary endpoint of PFS Patients switching to sotorasib will undergo a 28-day durvalumab washout and will receive sotorasib at 960 mg daily until progression Washout will be confirmed by ensuring that cycle 1 day 1 of sotorasib is scheduled for at least 28 days after the most recent durvalumab dose
Patients who 1 complete chemoradiation 2 have detectable ctDNA post chemoradiation 3 are without evidence of progressive disease on imaging 4 and are planned to start durvalumab consolidation then continue into the Monitoring Phase All other patients are no longer on trial and are taken off study Patients in the Monitoring Phase will have ctDNA measured again early-on during durvalumab consolidation ie cycle 3 of durvlalumab - 2 weeks in conjunction with standard of care imaging Patients with MRD will then continue to the Randomization Phase of trial
In the Randomization Phase patients will be randomized in a 11 fashion to continue standard of care durvalumab group 1 vs switch to sotorasib at 960 mg daily group 2 with the primary endpoint of PFS Patients switching to sotorasib will undergo a 28-day durvalumab washout and will receive sotorasib at 960 mg daily until progression Washout will be confirmed by ensuring that cycle 1 day 1 of sotorasib is scheduled for at least 28 days after the most recent durvalumab dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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