Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Stage IIIB/IV NSCLC non eligible to locoregional treatment with curative intent

• ALK rearrangement confirmed by IHC and/or FISH or NGS according to local methods

• Patient included in the EXPLORE ALK study

• Age \> or = 18 years

• Patient treated with first-line new generation ALKi

• Patient agrees to sign an informed consent form and to collect blood samples at inclusion, first tumor evaluation and progression and for whom tumor biopsy at diagnosis is available

• Patient enrolled in the french National Health Insurance program or with a third- party payer

Locations
Other Locations
France
Centre Hospitalier d'Aix en Provence
NOT_YET_RECRUITING
Aix-en-provence
Pneumologie CHU
NOT_YET_RECRUITING
Amiens
Centre Hospitalier Universitaire
NOT_YET_RECRUITING
Angers
Centre Hospitalier d'Annecy
RECRUITING
Annecy
Centre Hospitalier du Morvan
RECRUITING
Brest
Centre François Baclesse
NOT_YET_RECRUITING
Caen
Pneumologie CH Métropole Savoie
RECRUITING
Chambéry
Oncologie CLCC Jean Perrin
NOT_YET_RECRUITING
Clermont-ferrand
Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Pneumologie CH Eure-Seine
RECRUITING
Évreux
Pneumologie CHD Vendée
RECRUITING
La Roche-sur-yon
Pneumologie Hôpital Mignot
NOT_YET_RECRUITING
Le Chesnay
Pneumologie CH
NOT_YET_RECRUITING
Le Mans
Oncologie Centre Oscar Lombret
NOT_YET_RECRUITING
Lille
Pneumologie Hôpital Calmette
NOT_YET_RECRUITING
Lille
Pneumologie CHU Limoges
NOT_YET_RECRUITING
Limoges
Hôpital du Scorff
RECRUITING
Lorient
Centre Léon Bérard
RECRUITING
Lyon
Pneumologie Hôpital privé Jean Mermoz
NOT_YET_RECRUITING
Lyon
Oncologie Hôpital François Quesnay
NOT_YET_RECRUITING
Mantes-la-jolie
Hôpital Nord
RECRUITING
Marseille
Oncologie Institut Paoli Calmette
NOT_YET_RECRUITING
Marseille
Pneumologie Hôpital Européen
RECRUITING
Marseille
Hôpital de Meaux
NOT_YET_RECRUITING
Meaux
Oncologie Institut du Cancer de Montpellier
NOT_YET_RECRUITING
Montpellier
Oncologie CH Morlaix
NOT_YET_RECRUITING
Morlaix
Pneumologie CHR
RECRUITING
Orléans
Oncologie Institut Curie
NOT_YET_RECRUITING
Paris
Pneumologie Centre Hospitalier
RECRUITING
Pau
Hôpital du Haut Leveque
NOT_YET_RECRUITING
Pessac
CHU Pontchailloux
RECRUITING
Rennes
Hôpital Charles Nicolle
RECRUITING
Rouen
Pneumologie Hôpital Yves Le Foll
NOT_YET_RECRUITING
Saint-brieuc
Pneumologie CHU Félix Guyon
RECRUITING
Saint-denis
CHU La Réunion Site Sud
RECRUITING
Saint-pierre
Institut Lucien Neuwirth
RECRUITING
Saint-priest-en-jarez
Centre Paul Strauss
NOT_YET_RECRUITING
Strasbourg
Pneumologie Hôpital Foch
RECRUITING
Suresnes
Pneumologie HIA
NOT_YET_RECRUITING
Talence
Hôpital d'Instruction des Armées Ste Anne
RECRUITING
Toulon
Pneumologie Hôpital Sainte Musse
NOT_YET_RECRUITING
Toulon
Hôpital Larrey
NOT_YET_RECRUITING
Toulouse
Oncologie CH Bretagne-Atlantique
RECRUITING
Vannes
Centre Hospitalier de Villefranche sur Saone
RECRUITING
Villefranche-sur-saône
Oncologie Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Pneumologie CHI
NOT_YET_RECRUITING
Villeneuve-saint-georges
Contact Information
Primary
Florian GUISIER
florian.guisier@chu-rouen.fr
+33 2 32888079
Backup
Aurélie SWALDUZ
aurelie.swalduz@lyon.unicancer.fr
+33 469756217
Time Frame
Start Date: 2021-09-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
Other: Bioexalk cohort
All patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk.
Sponsors
Collaborators: Takeda
Leads: Groupe Francais De Pneumo-Cancerologie

This content was sourced from clinicaltrials.gov