RecruitingNot ApplicableNCT05122806

Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

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

Sponsor

Groupe Francais De Pneumo-Cancerologie

Enrollment

100 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer ALK Gene Rearrangement Positive

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational biobank study — not a treatment trial — collecting blood samples and tumor tissue from people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic rearrangement called ALK. The goal is to study the biological characteristics of this type of lung cancer, especially how it evolves and develops resistance to ALK-targeted drugs, to guide future treatment strategies. **You may be eligible if...** - You have stage IIIB or IV non-small cell lung cancer with a confirmed ALK rearrangement (by standard tumor testing) - You are already enrolled in the EXPLORE ALK study - You are being treated with a first-line ALK inhibitor drug (new generation) - You agree to provide blood samples at set timepoints and have tumor tissue available from diagnosis - You are 18 or older and enrolled in the French national health insurance program **You may NOT be eligible if...** - You do not wish to participate in the biobank study (BIOEXALK) - You are under legal guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICRNAseq

1. Tissue : RNAseq will be performed on tumor biopsy (10 slides of 5 microns) to identify the ALK fusion partner and its variant and associated co-mutations. 2. ctDNA : NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples

Locations(46)

Pneumologie CHU Félix Guyon

Saint-Denis, La Réunion, France

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 CH Eure-Seine

Évreux, 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

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NCT05122806

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