Actively Recruiting

Phase 2
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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