Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194448
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-12-20
Brief Title:
To Evaluate the EfficacySafety of Osimertinib Prior to CRT and Maintenance of it With Stage III Unresectable NSCLC With EGFR Mutations
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Open-label Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor EGFR Mutation-positive Stage III Unresectable Non-small Cell Lung Cancer NEOLA
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:
NEOLA
Brief Summary:
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in adult patients with Stage III unresectable NSCLC with common EGFR mutations exon 19 deletion or L858R
Detailed Description:
The study duration will be approximately 2 years for recruitment and 2 years of follow-up from the last patients initiation into the study
The induction treatment with osimertinib will be up to 8 weeks followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death
The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period every 3 weeks during the CRT period every 3 weeks for chemotherapy and daily visits for RT and every 12 weeks during the osimertinib maintenance treatment period
The induction treatment with osimertinib will be up to 8 weeks followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death
The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period every 3 weeks during the CRT period every 3 weeks for chemotherapy and daily visits for RT and every 12 weeks during the osimertinib maintenance treatment period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507798-16-00 | OTHER | EMA- EU CT number | None |