Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Recruiting · NCT05122806 · Interventional (participants receive a specific treatment) · Lead sponsor: Groupe Francais De Pneumo-Cancerologie
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Patients who do not wish to participate in Bioexalk
- Patients under guardianship
Where it is running
46 locations listed.
- Centre Hospitalier d'Aix en Provence - Aix-en-Provence, France
- Pneumologie CHU - Amiens, France
- Centre Hospitalier Universitaire - Angers, France
- Centre Hospitalier d'Annecy - Annecy, France
- Centre Hospitalier du Morvan - Brest, France
- Centre François Baclesse - Caen, France
- Pneumologie CH Métropole Savoie - Chambéry, France
- Oncologie CLCC Jean Perrin - Clermont-Ferrand, France
- Centre Hospitalier Intercommunal de Créteil - Créteil, France
- Pneumologie CHD Vendée - La Roche-sur-Yon, France
- Pneumologie Hôpital Mignot - Le Chesnay, France
- Pneumologie CH - Le Mans, France
- Oncologie Centre Oscar Lombret - Lille, France
- Pneumologie Hôpital Calmette - Lille, France
- Pneumologie CHU Limoges - Limoges, France
- Hôpital du Scorff - Lorient, France
- Pneumologie Hôpital privé Jean Mermoz - Lyon, France
- Centre Léon Bérard - Lyon, France
- Oncologie Hôpital François Quesnay - Mantes-la-Jolie, France
- Pneumologie Hôpital Européen - Marseille, France
- Oncologie Institut Paoli Calmette - Marseille, France
- Hôpital Nord - Marseille, France
- Hôpital de Meaux - Meaux, France
- Oncologie Institut du Cancer de Montpellier - Montpellier, France
- Oncologie CH Morlaix - Morlaix, France
- Pneumologie CHR - Orléans, France
- Oncologie Institut Curie - Paris, France
- Pneumologie Centre Hospitalier - Pau, France
- Hôpital du Haut Leveque - Pessac, France
- CHU Pontchailloux - Rennes, France
- Hôpital Charles Nicolle - Rouen, France
- Pneumologie Hôpital Yves Le Foll - Saint-Brieuc, France
- CHU La Réunion Site Sud - Saint-Pierre, France
- Institut Lucien Neuwirth - Saint-Priest-en-Jarez, France
- Centre Paul Strauss - Strasbourg, France
- Pneumologie Hôpital Foch - Suresnes, France
- Pneumologie HIA - Talence, France
- Pneumologie Hôpital Sainte Musse - Toulon, France
- Hôpital d'Instruction des Armées Ste Anne - Toulon, France
- Hôpital Larrey - Toulouse, France
- Oncologie CH Bretagne-Atlantique - Vannes, France
- Centre Hospitalier de Villefranche sur Saone - Villefranche-sur-Saône, France
- Oncologie Institut Gustave Roussy - Villejuif, France
- Pneumologie CHI - Villeneuve-Saint-Georges, France
- Pneumologie CH Eure-Seine - Évreux, France
- Pneumologie CHU Félix Guyon - Saint-Denis, La Réunion, France