Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04074993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2019-08-25
Brief Title:
Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays
Sponsor:
JI-YOUN HAN
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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 single-arm open-label study design Patients will receive brigatinib until disease progression unacceptable toxicity withdrawal of consent of death
Detailed Description:
Based on the clinical efficacy of ALK inhibitors in ALKNSCLC NCCN guidelines recommend ALK molecular testing of lung cancer patients to select patients for ALK-targeted therapy However molecular testing via tissue biopsy cannot always be performed on NSCLC patients potentially limiting access of effective treatment to the subset of patients who are able to undergo current testing procedures that utilize tissue biopsies Obtaining an adequate tissue biopsy specimen for NSCLC presents a number of challenges In particular the method for diagnosis of lung cancer depends on the location size and type of suspected lung cancer and the presence or absence of metastases Common procedures for centrally located tumors include bronchoscopy and sputum cytology which frequently yield insufficient tumor tissue for comprehensive mutation testing In addition 75 of patients are diagnosed with late-stage disease and often present with multiple comorbidities Biopsies in these patients can lead to complications such as pneumothorax hemoptysis other bleeding complications and cardiopulmonary decompensation As a result of these factors a physician treating a patient who presents with a significant burden of disease as well as significant comorbidities may rightly consider whether it is in the best interest of the patient to undergo a risky and potentially unsuccessful procedure Thus there exists a major unmet clinical need for testing procedures that do not require tumor tissue The purpose of this phase II study is to assess the efficacy of brigatinib in patients with advanced NSCLC harboring ALK rearrangement that are selected using predictive biomarkers identified via blood-based assays
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