Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05122806

Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

Led by Groupe Francais De Pneumo-Cancerologie · Updated on 2026-04-29

100

Participants Needed

46

Research Sites

301 weeks

Total Duration

On this page

Sponsors

G

Groupe Francais De Pneumo-Cancerologie

Lead Sponsor

T

Takeda

Collaborating Sponsor

AI-Summary

What this Trial Is About

BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients. BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study. Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA). For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon). Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.

CONDITIONS

Official Title

Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stage IIIB/IV non-small cell lung cancer not eligible for curative locoregional treatment
  • ALK rearrangement confirmed by IHC, FISH, or NGS using local methods
  • Patient included in the EXPLORE ALK study
  • Age 18 years or older
  • Treated with first-line new generation ALK inhibitor
  • Patient agrees to sign informed consent and provide blood samples at inclusion, first tumor evaluation, and progression
  • Tumor biopsy at diagnosis must be available
  • Enrolled in the French National Health Insurance program or covered by a third-party payer
Not Eligible

You will not qualify if you...

  • Patients who do not wish to participate in BioEXALK
  • Patients under guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 46 locations

1

Pneumologie CHU Félix Guyon

Saint-Denis, La Réunion, France, 97400

Actively Recruiting

2

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, France, 13616

Not Yet Recruiting

3

Pneumologie CHU

Amiens, France, 80054

Not Yet Recruiting

4

Centre Hospitalier Universitaire

Angers, France, 49033

Not Yet Recruiting

5

Centre Hospitalier d'Annecy

Annecy, France, 74374

Actively Recruiting

6

Centre Hospitalier du Morvan

Brest, France, 29200

Actively Recruiting

7

Centre François Baclesse

Caen, France, 14000

Not Yet Recruiting

8

Pneumologie CH Métropole Savoie

Chambéry, France, 73000

Actively Recruiting

9

Oncologie CLCC Jean Perrin

Clermont-Ferrand, France, 63000

Not Yet Recruiting

10

Centre Hospitalier Intercommunal de Créteil

Créteil, France, 94010

Actively Recruiting

11

Pneumologie CH Eure-Seine

Évreux, France, 27000

Actively Recruiting

12

Pneumologie CHD Vendée

La Roche-sur-Yon, France, 85925

Actively Recruiting

13

Pneumologie Hôpital Mignot

Le Chesnay, France, 78157

Not Yet Recruiting

14

Pneumologie CH

Le Mans, France, 72000

Not Yet Recruiting

15

Oncologie Centre Oscar Lombret

Lille, France, 59000

Not Yet Recruiting

16

Pneumologie Hôpital Calmette

Lille, France, 59000

Not Yet Recruiting

17

Pneumologie CHU Limoges

Limoges, France, 87042

Not Yet Recruiting

18

Hôpital du Scorff

Lorient, France, 56100

Actively Recruiting

19

Pneumologie Hôpital privé Jean Mermoz

Lyon, France, 69085

Not Yet Recruiting

20

Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

21

Oncologie Hôpital François Quesnay

Mantes-la-Jolie, France, 78200

Not Yet Recruiting

22

Pneumologie Hôpital Européen

Marseille, France, 130003

Actively Recruiting

23

Oncologie Institut Paoli Calmette

Marseille, France, 13273

Not Yet Recruiting

24

Hôpital Nord

Marseille, France, 13915

Actively Recruiting

25

Hôpital de Meaux

Meaux, France, 77100

Actively Recruiting

26

Oncologie Institut du Cancer de Montpellier

Montpellier, France, 34298

Not Yet Recruiting

27

Oncologie CH Morlaix

Morlaix, France, 29600

Not Yet Recruiting

28

Pneumologie CHR

Orléans, France, 45000

Actively Recruiting

29

Oncologie Institut Curie

Paris, France, 75005

Not Yet Recruiting

30

Pneumologie Centre Hospitalier

Pau, France, 64000

Actively Recruiting

31

Hôpital du Haut Leveque

Pessac, France, 33604

Not Yet Recruiting

32

CHU Pontchailloux

Rennes, France, 35000

Actively Recruiting

33

Hôpital Charles Nicolle

Rouen, France, 76031

Actively Recruiting

34

Pneumologie Hôpital Yves Le Foll

Saint-Brieuc, France, 22000

Not Yet Recruiting

35

CHU La Réunion Site Sud

Saint-Pierre, France, 97410

Actively Recruiting

36

Institut Lucien Neuwirth

Saint-Priest-en-Jarez, France, 42271

Actively Recruiting

37

Centre Paul Strauss

Strasbourg, France, 67065

Not Yet Recruiting

38

Pneumologie Hôpital Foch

Suresnes, France, 92150

Actively Recruiting

39

Pneumologie HIA

Talence, France, 33400

Not Yet Recruiting

40

Pneumologie Hôpital Sainte Musse

Toulon, France, 83056

Not Yet Recruiting

41

Hôpital d'Instruction des Armées Ste Anne

Toulon, France, 83800

Actively Recruiting

42

Hôpital Larrey

Toulouse, France, 31059

Not Yet Recruiting

43

Oncologie CH Bretagne-Atlantique

Vannes, France, 56000

Actively Recruiting

44

Centre Hospitalier de Villefranche sur Saone

Villefranche-sur-Saône, France, 69655

Actively Recruiting

45

Oncologie Institut Gustave Roussy

Villejuif, France, 94805

Not Yet Recruiting

46

Pneumologie CHI

Villeneuve-Saint-Georges, France, 94195

Not Yet Recruiting

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Research Team

F

Florian GUISIER

CONTACT

A

Aurélie SWALDUZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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