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

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 19, 2025

Primary Completion Date

October 1, 2030

Study Completion Date

October 1, 2030

Conditions
NSCLC
Interventions
BIOLOGICAL

Blood samples for Hematology

Complete blood count will include erythrocytes, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, leukocytes, hemoglobin, hematocrit.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

PROCEDURE

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.

PROCEDURE

Local Ablative Therapy (LAT)

Local Ablative Treatment (LAT) (stereotactic body radiotherapy, surgery, thermal ablation)

Trial Locations (27)

13915

NOT_YET_RECRUITING

Hôpital Nord, Marseille

14000

NOT_YET_RECRUITING

Centre François Baclesse, Caen

21079

NOT_YET_RECRUITING

Centre Georges-François Leclerc, Dijon

29200

NOT_YET_RECRUITING

CHU de Brest, Brest

30029

NOT_YET_RECRUITING

CHU de Nîmes, Nîmes

33800

WITHDRAWN

CHU de Bordeaux Haut Lévêque, Pessac

35000

NOT_YET_RECRUITING

CHU Rennes, Hôpital Pontchaillou, Rennes

35033

NOT_YET_RECRUITING

CHU Ponchailloux, Rennes

41260

NOT_YET_RECRUITING

Polyclinique de Blois, La Chaussée-Saint-Victor

42270

NOT_YET_RECRUITING

Pneumologie CHU St Etienne, Saint-Etienne

45067

NOT_YET_RECRUITING

CHU Orléans, Orléans

54000

RECRUITING

CHRU de Nancy, Nancy

56017

NOT_YET_RECRUITING

CH Bretagne Atlantique, Vannes

67065

NOT_YET_RECRUITING

Centre Paul Strauss, Strasbourg

68000

NOT_YET_RECRUITING

Hôpital Louis Pasteur, Colmar

69373

WITHDRAWN

Centre Leon Bérard, Lyon

69655

NOT_YET_RECRUITING

Centre Hospitalier de Villefranche sur Saone, Villefranche-sur-Saône

73000

NOT_YET_RECRUITING

CH Métropole-Savoie, Chambéry

74370

NOT_YET_RECRUITING

CH Annecy, Épagny

75020

NOT_YET_RECRUITING

Hôpital Tenon, Paris

76031

NOT_YET_RECRUITING

Hôpital Charles Nicolle, Rouen

83800

NOT_YET_RECRUITING

HIA St Anne, Toulon

85000

NOT_YET_RECRUITING

CHD les Oudaries, La Roche-sur-Yon

87042

NOT_YET_RECRUITING

CHU Dupuytren, Limoges

94010

NOT_YET_RECRUITING

Pneumologie Centre Hospitalier Intercommunal de Créteil, Créteil

97410

NOT_YET_RECRUITING

CHU de la Réunion, Saint-Pierre

06189

RECRUITING

CLCC Antoine Lacassagne, Nice

All Listed Sponsors
lead

Groupe Francais De Pneumo-Cancerologie

OTHER

NCT06620835 - 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 | Biotech Hunter | Biotech Hunter