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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
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-06-19
Completion Date
2030-10-01
Last Updated
2025-07-29
Healthy Volunteers
No
Conditions
Interventions
Blood samples for Hematology
Complete blood count will include erythrocytes, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, leukocytes, hemoglobin, hematocrit.
Blood samples for Chemistry
Clinical chemistry will include serum electrolytes (sodium, potassium, calcium, corrected calcium for hypoalbuminemia), creatinine, CrCl with local formula, and fasting blood glucose.
Blood sample for liver function tests
Laboratory tests to assess liver function will include Aminotransferase Alanine (ALAT), Aminotransferase Aspartate (ASAT), Phosphatase Alkaline (ALP), Gamma-glutamyl Transferase (GGT), total and conjugated bilirubin.
Pregnancy test
Pregnancy test will be performed in women of childbearing potential, including women who have had a tubal ligation. Childbearing potential is defined as not having undergone surgical sterilization, hysterectomy, and/or bilateral oophorectomy or not being postmenopausal (≥12 months of amenorrhea). Urine pregnancy tests will be based on the measurement of β-Human Chorionic Gonadotropin (HCG). If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed at screening.
Tumour assessment
Tumor assessment according to the RECIST v1.1 include the following radiological evaluation: thoracic CT scan, brain MRI or CT scan (MRI is preferred), abdominopelvic scan, PET-CT scan mandatory and at the Investigator's discretion, if needed bone scintigraphy and chest X-ray.
Local Ablative Therapy (LAT)
Local Ablative Treatment (LAT) (stereotactic body radiotherapy, surgery, thermal ablation)
Locations (27)
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
Centre Leon Bérard
Lyon, France
Hôpital Nord
Marseille, France
CHRU de Nancy
Nancy, France
CLCC Antoine Lacassagne
Nice, France
CHU de Nîmes
Nîmes, France
CHU Orléans
Orléans, France
Hôpital Tenon
Paris, France
CHU de Bordeaux Haut Lévêque
Pessac, France
CHU Rennes, Hôpital Pontchaillou
Rennes, France
CHU Ponchailloux
Rennes, France
Hôpital Charles Nicolle
Rouen, France
Pneumologie CHU St Etienne
Saint-Etienne, France
CHU de la Réunion
Saint-Pierre, France
Centre Paul Strauss
Strasbourg, France
HIA St Anne
Toulon, France
CH Bretagne Atlantique
Vannes, France
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, France