Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564844
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Phase III Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care Following Complete Tumour Resection in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomised Open-label Global Study of Adjuvant Datopotamab Deruxtecan Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care Following Complete Tumour Resection in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features TROPION-Lung12
Status:
NOT_YET_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:
TROPION-Lung12
Brief Summary:
This is a Phase III randomised open-label multicentre global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC after complete surgical resection R0 in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive as determined by the Sponsor-designated ctDNA assay or have at least one high-risk pathological feature
Detailed Description:
The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC after complete surgical resection R0 in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive as determined by the Sponsor-designated ctDNA assay or have at least one high-risk pathological feature
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