Ignite Creation Date:
2025-12-18 @ 9:27 AM
Ignite Modification Date:
2025-12-18 @ 9:27 AM
Study NCT ID:
NCT06606847
Status:
None
Last Update Posted:
2025-09-15 00:00:00
First Post:
2024-09-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase II, Open-label, Multicentre, Single-arm Study of Durvalumab Plus Oleclumab in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy (LADOGA)
Status:
None
Status Verified Date:
2025-09
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:
LADOGA
Brief Summary:
This is a Phase II, open-label, multicentre, single-arm study assessing the efficacy and safety of durvalumab in combination with oleclumab in participants with locally advanced (Stage III), unresectable NSCLC with WHO performance status of 0 or 1, who have not progressed on prior platinum-based CRT.
All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
Detailed Description:
None
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?: