Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05034055
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-08-27
Brief Title:
Study of Stereotactic Ablative RadiotherapySBRT Followed by Atezolizumab Tiragolumab in Treatment-naive Patients With Metastatic Non-small Cell Lung Cancer
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Phase 2 Study of Stereotactic Ablative RadiotherapySBRT Followed by Atezolizumab Tiragolumab in Treatment-naive Patients With Metastatic Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2021-09
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:
SKYROCKET
Brief Summary:
Radiation can induce immunogenic cell death local release of inflammatory cytokines and damage associated molecular patterns DAMPs resulting in local effects on endothelial cell expression of adhesion receptors increased immune cell trafficking and immune cell activation Dose fractionation and volume of radiation can influence immunologic effects in the tumor microenvironment Nonclinical studies suggest that despite an initial local depletion of lymphocytes hypofractionated regimens of radiation may be immune activating Additionally recent work suggests that standard fractionation and hypofractionation induce expansion of unique immune populations with standard fractionation favoring a myeloid response and hypofractionation driving a lymphoid response that may be more favorable to adaptive anti-tumor immunity Compared to high doses of radiation which induce immunogenic cell death dose-dependent increases of MHC-I and death receptors moderate fractional doses of 3-10 Gy may be optimal for activating a type I IFN response in tumor cells via a dose-dependent increase in the cytoplasmic leakage of DNA from micronuclei which activates the cyclic GMP-AMP synthasestimulator of interferon genes cGASSTING pathway Extensive experimental evidence indicates that radiotherapy can work in synergy with immunotherapy to generate T cells that reject not only the irradiated tumor but also the metastases outside of the field of irradiation which offers a rationale for utilizing radiotherapy to enhance response to immunotherapy where tumors are unlikely to respond to immunotherapy alone
Detailed Description:
All patients will receive 1200mg atezolizumab administered by IV infusion on Day 1 of each 21-day cycle after completion of stereotactic body radiotherapy SBRT for 215 days No escalations or reductions in the dose of the investigational product will be allowedFollowing the administration of atezolizumab patients will receive 600mg tiragolumab administered by IV infusion on Day 1 of each 21-day cycle The tiragolumab dose is fixed and is not dependent on body weight
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