Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-04 @ 6:20 AM
Study NCT ID:
NCT06620835
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Groupe Francais De Pneumo-Cancerologie
Organization:
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:
RECRUITING
Status Verified Date:
2025-07
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:
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 1.1)
* 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 1.1)
* 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:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A00356-41 | OTHER | ANSM/CPP | View |