Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925530
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-06-22
Brief Title:
Study to Assess Neoadjuvant Durvalumab D and Platinum-Based Chemotherapy CT Followed by Either Surgery and Adjuvant D or CRT and Consolidation D in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC MDT-BRIDGE
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicentre Phase II Single-Arm Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy CT Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy CRT and Consolidation Durvalumab in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer NSCLC
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MDT-BRIDGE
Brief Summary:
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy CT given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy CRT and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC
Detailed Description:
This will be a multicentre Phase II single-arm global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT given intravenously followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC
Neoadjuvant Period A
All participants will initially receive 2 cycles of neoadjuvant durvalumab CT investigators choice platinum-based every three weeks Participants will be assessed for resectability by a multidisciplinary team
Neoadjuvant Period B
Cohort 1 Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles followed by surgery
CRT
Cohort 2 Participants with unresectable tumours according to MDT re-assessment will receive definitive CRT 6 one-week cycles for approximately six weeks
Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year
Neoadjuvant Period A
All participants will initially receive 2 cycles of neoadjuvant durvalumab CT investigators choice platinum-based every three weeks Participants will be assessed for resectability by a multidisciplinary team
Neoadjuvant Period B
Cohort 1 Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles followed by surgery
CRT
Cohort 2 Participants with unresectable tumours according to MDT re-assessment will receive definitive CRT 6 one-week cycles for approximately six weeks
Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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