Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287775
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-02-29
Brief Title:
Testing the Combination of an Anti-cancer Drug Iadademstat With Other Anti-cancer Drugs Atezolizumab or Durvalumab at Improving Outcomes for Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
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:
None
Brief Summary:
This phase III trial tests the safety side effects and best dose of iadademstat when given together with atezolizumab or durvalumab and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body extensive stage who initially received standard of care chemotherapy and immunotherapy Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Immunotherapy with monoclonal antibodies such as atezolizumab or durvalumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare the progression-free survival PFS between the combination of iadademstat plus immune checkpoint inhibitor ICI versus ICI maintenance alone
SECONDARY OBJECTIVES
I To compare objective response rate ORR and overall survival OS between treatment arms
II To evaluate the safety of combination iadademstat plus ICI
EXPLORATORY OBJECTIVES
I To assess whether detection of circulating tumor DNA ctDNA minimal residual disease correlates with disease progression
II To assess whether iadademstat impacts the correlation of ICI atezolizumab or durvalumab baseline and time varying clearance with clinical outcomes PFS and OS and the presence of cachexia
III To explore exposure response relationships of iadademstat in combination with ICIs
IV To characterize changes to small cell lung cancer SCLC subtype throughout treatment
OUTLINE This is a phase I dose-escalation study of iadademstat in combination with atezolizumab and durvalumab followed by a randomized phase II study
PHASE I Patients receive iadademstat orally PO on days 1 8 15 and 22 or days 1 and 15 of each cycle Patients also continue receiving their initial ICI treatment either atezolizumab intravenously IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
PHASE II Patients are randomized to 1 of 2 arms
ARM I Patients receive iadademstat PO on days 1 8 15 and 22 or days 1 and 15 of each cycle Patients also continue receiving their initial ICI treatment either atezolizumab IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients continue receiving their initial ICI treatment either atezolizumab IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
All patients also undergo multi-gated acquisition MUGA or echocardiogram ECHO brain magnetic resonance imaging MRI or brain computed tomography CT during screening and CT scans and blood sample collection throughout the trial Patients may also undergo an optional tumor biopsy on study
After completion of study treatment patients are followed up every 3 months for up to 12 months
I To compare the progression-free survival PFS between the combination of iadademstat plus immune checkpoint inhibitor ICI versus ICI maintenance alone
SECONDARY OBJECTIVES
I To compare objective response rate ORR and overall survival OS between treatment arms
II To evaluate the safety of combination iadademstat plus ICI
EXPLORATORY OBJECTIVES
I To assess whether detection of circulating tumor DNA ctDNA minimal residual disease correlates with disease progression
II To assess whether iadademstat impacts the correlation of ICI atezolizumab or durvalumab baseline and time varying clearance with clinical outcomes PFS and OS and the presence of cachexia
III To explore exposure response relationships of iadademstat in combination with ICIs
IV To characterize changes to small cell lung cancer SCLC subtype throughout treatment
OUTLINE This is a phase I dose-escalation study of iadademstat in combination with atezolizumab and durvalumab followed by a randomized phase II study
PHASE I Patients receive iadademstat orally PO on days 1 8 15 and 22 or days 1 and 15 of each cycle Patients also continue receiving their initial ICI treatment either atezolizumab intravenously IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
PHASE II Patients are randomized to 1 of 2 arms
ARM I Patients receive iadademstat PO on days 1 8 15 and 22 or days 1 and 15 of each cycle Patients also continue receiving their initial ICI treatment either atezolizumab IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients continue receiving their initial ICI treatment either atezolizumab IV over 30-60 minutes on day 1 of each cycle or durvalumab IV over 60 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
All patients also undergo multi-gated acquisition MUGA or echocardiogram ECHO brain magnetic resonance imaging MRI or brain computed tomography CT during screening and CT scans and blood sample collection throughout the trial Patients may also undergo an optional tumor biopsy on study
After completion of study treatment patients are followed up every 3 months for up to 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186691 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186691 |
| NCI-2024-01398 | REGISTRY | None | None |
| 10629 | OTHER | None | None |
| 10629 | OTHER | None | None |