Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606847
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
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:
None
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:
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:
LADOGA
Brief Summary:
The purpose of this Phase II open-label multicentre single-arm study is to assess efficacy and safety of durvalumab MEDI4736 in combination with oleclumab MEDI9447 in participants with locally advanced Stage III unresectable non-small cell lung cancer NSCLC who have not progressed following platinum-based concurrent or sequential chemoradiotherapy cCRT or sCRT
Detailed Description:
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 11-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 11-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
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