Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05015010
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-03
First Post:
2021-08-16
Brief Title:
Alectinib in Neo-adjuvant Treatment of Stage III NSCLC
Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Organization:
Gruppo Oncologico Italiano di Ricerca Clinica
Study Overview
Official Title:
Phase II Open-label Single-arm Multicenter Study to Assess the Activity and Safety of ALectinib as NEO-adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase-positive ALK Locally Advanced Stage III Non-Small Cell Lung Cancer NSCLC ALNEO Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
ALNEO
Brief Summary:
Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations Across this wide spectrum of heterogeneity there is no single deļ¬nitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach In this trial we want to test in ALK positive stage III locally advanced NSCLC patients the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence with a limited risk of toxicity related in long term administration after surgery
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