Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-02-21
Brief Title:
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy Durvalumab and Surgery in Patients with Early-stage Operable Non-small Cell Lung Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
An International Multicentre Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients with Stage IIB-IIIB N2 Resectable NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
ADOPT-lung
Brief Summary:
ADOPT-LUNG is an international multicentre open-label randomised phase III trial Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy followed by surgery Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles experimental arm or observation control arm The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival DFS in patients who do not achieve complete pathological response pCR as per local assessment according to the IASLC recommendations
Detailed Description:
None
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