Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT05546866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Open-label, Prospective, Multi-center, Single-arm Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in Non-small Cell Lung Cancer (NSCLC) With Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm)
Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.
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?: