Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620835
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Trial for Local Ablative Treatment LAT Optimization in Patients With Advanced Non-Small Cells Lung Cancer NSCLC Presenting an Anaplastic Lymphoma Kinase ALK Rearrangement Treated by Brigatinib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimization of Treatment With Brigatinib in Patients With Advanced NSCLC Harboring an ALK Rearrangement by LAT at the Time of Best Response A Multicenter Open Phase Two Trial OPTALK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
OPTALK
Brief Summary:
The goal of this clinical trial is to learn if the treatment by systemic Brigatinib ALUNBRIG associated to local ablative therapy LAT treatment is improved if administered when the brigatinib works best in participants presenting an advanced non-small cells lung cancer with an ALK gene anomaly this anomaly produces a defective protein that is responsible for the multiplication of cancer cells
This clinical trial is expected to involve 45 participants in several sites in France
Advanced non-small cell lung cancer NSCLC participants with ALK rearrangements treated with brigatinib in first line of non-curable setting will be screened
If the disease assessment done between 3 to 9 months after initiation of brigatinib shows
a tumor response or stabilization according to RECIST 11
a disease which meets the definition of an oligometastatic disease five metastatic lesions or less and a maximum of two lesions per organ
all tumor targets are accessible to a local ablative therapy confirmed by an expert panel of clinicians before inclusion surgery stereotactic radiosurgery SRS For liver adrenal or other metastases percutaneous thermal ablation will be accepted
Participants will be asked to visit the clinic
for eligibility criteria assessment prior to LAT
for LAT
every 8 weeks for checkups and tests the first year after LAT
and then every 12 weeks for a maximum period of 3 years
Eligible patients will benefit from local ablative therapy with continuation of brigatinib
This clinical trial is expected to involve 45 participants in several sites in France
Advanced non-small cell lung cancer NSCLC participants with ALK rearrangements treated with brigatinib in first line of non-curable setting will be screened
If the disease assessment done between 3 to 9 months after initiation of brigatinib shows
a tumor response or stabilization according to RECIST 11
a disease which meets the definition of an oligometastatic disease five metastatic lesions or less and a maximum of two lesions per organ
all tumor targets are accessible to a local ablative therapy confirmed by an expert panel of clinicians before inclusion surgery stereotactic radiosurgery SRS For liver adrenal or other metastases percutaneous thermal ablation will be accepted
Participants will be asked to visit the clinic
for eligibility criteria assessment prior to LAT
for LAT
every 8 weeks for checkups and tests the first year after LAT
and then every 12 weeks for a maximum period of 3 years
Eligible patients will benefit from local ablative therapy with continuation of brigatinib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None