Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564870
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Observational Study of the Efficacy and Safety of DURVALUMAB Maintenance Therapy in Patients With Stage III Non-Small Cell Lung Cancer DURVABREIZH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
DURVABREIZH
Brief Summary:
The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy
Detailed Description:
Immune checkpoint inhibitors ICIs such as anti-PD-1PD-L1 have revolutionized the field of immuno-oncology inducing significant and durable responses in patients with all types of tumor and in particular advanced stage II-IV non-small cell lung cancer NSCLC The use of durvalumab in consolidation after radiochemotherapy in locally advanced NSCLC has significantly improved progression-free survival and overall survival see PACIFIC trial Durvalumab now has marketing authorization for this indication in cases of PD-L11 overexpression on tumor cells
However 50 of patients experience tumor progression at 1 year and there is currently no biomarker clinical biological or radiological predictive of tumor response to durvalumab in consolidation
Elucidating the determinants of response and resistance to treatment as well as predicting severe immune-mediated adverse events are essential to improving patient outcomes and developing new therapeutic strategies
Translated with DeepLcom free version
However 50 of patients experience tumor progression at 1 year and there is currently no biomarker clinical biological or radiological predictive of tumor response to durvalumab in consolidation
Elucidating the determinants of response and resistance to treatment as well as predicting severe immune-mediated adverse events are essential to improving patient outcomes and developing new therapeutic strategies
Translated with DeepLcom free version
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