Actively Recruiting
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
Led by Groupe Francais De Pneumo-Cancerologie · Updated on 2026-04-29
45
Participants Needed
27
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at diagnosis
- Stage 3 NSCLC not eligible for chemoradiotherapy or stage 4 NSCLC confirmed by tissue or cytology
- No prior treatment with Tyrosine Kinase Inhibitors (TKI)
- ALK gene rearrangements confirmed by validated testing methods
- Stable disease or response after 3 to 9 months of brigatinib treatment per RECIST 1.1
- At least one residual tumor site suitable for local ablative therapy
- Oligometastatic disease with five or fewer metastatic lesions and up to two lesions per organ
- Eligible for local ablative treatments such as surgery, stereotactic radiosurgery, radiotherapy, radiofrequency, or cryotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy greater than 12 weeks
- Asymptomatic brain metastases allowed
- No other malignant tumors in the past 5 years except specific treated carcinomas and low-grade prostate cancer
- Adequate organ function shown by lab tests before treatment
- For women of childbearing potential, use effective non-hormonal contraception during and for 4 months after treatment
- For men with female partners of childbearing potential, use effective contraception during and for 3 months after treatment
- Signed informed consent
- Affiliated with or benefiting from French social security
You will not qualify if you...
- NSCLC without known ALK gene rearrangements
- Neuroendocrine tumors
- Uncontrolled or untreated superior vena cava syndrome
- Unstable or symptomatic brain metastases despite corticosteroids
- Tumors not suitable for local therapy, including leptomeningeal, pericardial, pleural, mesenteric lesions, and lymphangitic spread
- Serious medical conditions in the past 6 months such as severe angina, recent heart surgery, severe heart failure, ischemic stroke, grade 2 or higher peripheral neuropathy, or psychiatric/neurological disorders affecting consent
- Severe or uncontrolled systemic diseases incompatible with the study
- Severe infections within 4 weeks before inclusion
- Psychological, family, social, or geographic factors interfering with study monitoring
- Legal protections preventing consent (guardianship, imprisonment, pregnancy, breastfeeding, minors)
- Participation in other interventional studies within 4 weeks before starting this study
- Known allergies or adverse reactions to study drugs
- Lung function not suitable for surgery or radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
CHU de Brest
Brest, France, 29200
Not Yet Recruiting
2
Centre François Baclesse
Caen, France, 14000
Not Yet Recruiting
3
CH Métropole-Savoie
Chambéry, France, 73000
Not Yet Recruiting
4
Hôpital Louis Pasteur
Colmar, France, 68000
Not Yet Recruiting
5
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94010
Not Yet Recruiting
6
Centre Georges-François Leclerc
Dijon, France, 21079
Not Yet Recruiting
7
CH Annecy
Épagny, France, 74370
Not Yet Recruiting
8
Polyclinique de Blois
La Chaussée-Saint-Victor, France, 41260
Not Yet Recruiting
9
CHD les Oudaries
La Roche-sur-Yon, France, 85000
Not Yet Recruiting
10
CHU Dupuytren
Limoges, France, 87042
Not Yet Recruiting
11
Centre Leon Bérard
Lyon, France, 69373
Withdrawn
12
Hôpital Nord
Marseille, France, 13915
Not Yet Recruiting
13
CHRU de Nancy
Nancy, France, 54000
Actively Recruiting
14
CLCC Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
15
CHU de Nîmes
Nîmes, France, 30029
Not Yet Recruiting
16
CHU Orléans
Orléans, France, 45067
Not Yet Recruiting
17
Hôpital Tenon
Paris, France, 75020
Actively Recruiting
18
CHU de Bordeaux Haut Lévêque
Pessac, France, 33800
Withdrawn
19
CHU Rennes, Hôpital Pontchaillou
Rennes, France, 35000
Not Yet Recruiting
20
CHU Ponchailloux
Rennes, France, 35033
Not Yet Recruiting
21
Hôpital Charles Nicolle
Rouen, France, 76031
Not Yet Recruiting
22
Pneumologie CHU St Etienne
Saint-Etienne, France, 42270
Not Yet Recruiting
23
CHU de la Réunion
Saint-Pierre, France, 97410
Not Yet Recruiting
24
Centre Paul Strauss
Strasbourg, France, 67065
Not Yet Recruiting
25
HIA St Anne
Toulon, France, 83800
Not Yet Recruiting
26
CH Bretagne Atlantique
Vannes, France, 56017
Not Yet Recruiting
27
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, France, 69655
Not Yet Recruiting
Research Team
H
Hubert CURCIO
CONTACT
S
Soizic FERLANDIN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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