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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Brest
Brest, France
Centre François Baclesse
Caen, France
CH Métropole-Savoie
Chambéry, France
Hôpital Louis Pasteur
Colmar, France
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre Georges-François Leclerc
Dijon, France
CH Annecy
Épagny, France
Polyclinique de Blois
La Chaussée-Saint-Victor, France
CHD les Oudaries
La Roche-sur-Yon, France
CHU Dupuytren
Limoges, France
Start Date
June 19, 2025
Primary Completion Date
October 1, 2030
Completion Date
October 1, 2030
Last Updated
July 29, 2025
45
ESTIMATED participants
Blood samples for Hematology
BIOLOGICAL
Blood samples for Chemistry
BIOLOGICAL
Blood sample for liver function tests
BIOLOGICAL
Pregnancy test
BIOLOGICAL
Tumour assessment
PROCEDURE
Local Ablative Therapy (LAT)
PROCEDURE
Lead Sponsor
Groupe Francais De Pneumo-Cancerologie
NCT07486219
NCT06305754
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05098132