Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04621188
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2020-11-04
Brief Title:
Lorlatinib After Failure of First-line TKI in Patients with Advanced ROS1-positive NSCLC ALBATROS
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
A Phase II Single-group Assignment Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Tyrosine Kinase Inhibitor in Patients with Advanced ROS1-positive Non-small Cell Lung Cancer ALBATROS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ROS1 rearrangements are present in 1-2 of NSCLC cases and define a distinct molecular subgroup Like ALK anaplastic lymphoma kinase rearrangements in NSCLC ROS1 fusions confer sensitivity to the inhibitor crizotinib Crizotinib which is a tyrosine kinase inhibitor TKI has been shown to be effective in tumors in several retrospective studies
Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC This indication is based on the results of pooled data from several trials Together these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion
However despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC patients will develop resistance to these tyrosine kinase inhibitors
Lorlatinib is a new and potent ROS1 ALK inhibitor optimized to penetrate the blood-brain barrier A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation In this situation lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations lorlatinib could be a treatment of choice in ROS1-positive NSCLC
Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC This indication is based on the results of pooled data from several trials Together these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion
However despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC patients will develop resistance to these tyrosine kinase inhibitors
Lorlatinib is a new and potent ROS1 ALK inhibitor optimized to penetrate the blood-brain barrier A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation In this situation lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations lorlatinib could be a treatment of choice in ROS1-positive NSCLC
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