Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04317651
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2020-03-19
Brief Title:
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Sponsor:
Fondazione Ricerca Traslazionale
Organization:
Fondazione Ricerca Traslazionale
Study Overview
Official Title:
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
SPECIALK
Brief Summary:
This is a multicenter observational retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting
Detailed Description:
Primary efficacy objective
To assess the efficacy of crizotinib in real life setting
Secondary objectives
1 To evaluate the therapeutic response to crizotinib-based treatment
2 To identify additional biomarkers selectively present in the ALK positive population
3 To assess the safety of crizotinib 250 mgbid in the treatment of NSCLC in real life setting
Non-small-cell Lung Cancer NSCLC remains the leading cause of cancer death in Western Countries Identification of anaplastic lymphoma kinase ALK gene rearrangements reinforced the role of targeted therapies in lung cancer The EML4-ALK fusion gene is detected in 3-7 of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features including young age absent or minimal smoking history and adenocarcinoma histology However such clinical features do not properly select patients for ALK inhibitors ALK-Is and consequently molecular testing is mandatory Indeed current guidelines recommend to test ALK rearrangements at diagnosis all patients with advanced lung adenocarcinoma due to immediate therapeutic implications
To assess the efficacy of crizotinib in real life setting
Secondary objectives
1 To evaluate the therapeutic response to crizotinib-based treatment
2 To identify additional biomarkers selectively present in the ALK positive population
3 To assess the safety of crizotinib 250 mgbid in the treatment of NSCLC in real life setting
Non-small-cell Lung Cancer NSCLC remains the leading cause of cancer death in Western Countries Identification of anaplastic lymphoma kinase ALK gene rearrangements reinforced the role of targeted therapies in lung cancer The EML4-ALK fusion gene is detected in 3-7 of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features including young age absent or minimal smoking history and adenocarcinoma histology However such clinical features do not properly select patients for ALK inhibitors ALK-Is and consequently molecular testing is mandatory Indeed current guidelines recommend to test ALK rearrangements at diagnosis all patients with advanced lung adenocarcinoma due to immediate therapeutic implications
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