Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634199
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy cCRT and IO Treatment in Non-resectable Stage IIIAB and IIIC NSCLC Patients Treated in Real World
Status:
NOT_YET_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:
SIENNA
Brief Summary:
Observational multicenter one-arm non-comparative study Data will be recorded in a retrospectively manner The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits The primary objective is describe the antitumor immune response generated in the context of IO immunotherapy treatment after cCRT in patients with unresectable NSCLC treated in real world
Detailed Description:
The study is based on the collection of blood samples and tumor sample analysis in real world NSCLC stage IIIAB and IIIC PD-L11 non-resectable patients on treatment with IO after cCRT without progression The patients participating in this study will not receive treatment in relation to the study no drugs will be provided Patients will be treated as per standard clinical practice All data collected for this study will be collected retrospectively from patient clinical chart Only secondary data collected will be analyzed together will samples analysis informationThe duration of the study is expected to be 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None