Brief 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.

Conditions

• Non-small Cell Lung Cancer
• ALK Gene Rearrangement Positive

Intervention / Treatment

• Genetic: RNAseq

Primary Outcome Measures

• Progression Free Survival (PFS) (From date of treatment initiation up to 72 months)
  PFS assessed by local review using RECIST v1.1, defined as time from treatment initiation to the first clinical or radiological progression or death from any cause

Countries

France

Locations and Investigators

• Pneumologie CHU Félix Guyon, Saint-Denis, France (Recruiting)
  • Diane MOREAU
• Centre Hospitalier d'Aix en Provence, Aix-en-Provence, France (Not yet recruiting)
  • Stéphanie MARTINEZ
  • Stéphanie MARTINEZ (Principal Investigator)
• Pneumologie CHU, Amiens, France (Not yet recruiting)
  • Géraldine FRANCOIS
• Centre Hospitalier Universitaire, Angers, France (Not yet recruiting)
  • Thierry URBAN
  • Thierry URBAN (Principal Investigator)
• Centre Hospitalier d'Annecy, Annecy, France (Recruiting)
  • Chantal DECROISETTE
  • Chantal H DECROISETTE (Principal Investigator)
• Centre Hospitalier du Morvan, Brest, France (Recruiting)
  • Renaud DESCOURT, PhD
  • Renaud DESCOURT, PhD (Principal Investigator)
• Centre François Baclesse, Caen, France (Not yet recruiting)
  • Radj GERVAIS
  • Radj GERVAIS (Principal Investigator)
• Pneumologie CH Métropole Savoie, Chambéry, France (Recruiting)
  • Julian PINSOLLE
• Oncologie CLCC Jean Perrin, Clermont-Ferrand, France (Not yet recruiting)
  • Lise THIBONNIER
• Centre Hospitalier Intercommunal de Créteil, Créteil, France (Recruiting)
  • Gaelle ROUSSEAU-BUSSAC, PhD
  • Gaelle ROUSSEAU-BUSSAC, PhD (Principal Investigator)
• Pneumologie CH Eure-Seine, Évreux, France (Recruiting)
  • Nicolas DELBERGHE
• Pneumologie CHD Vendée, La Roche-sur-Yon, France (Recruiting)
  • Marie MARCQ
• Pneumologie Hôpital Mignot, Le Chesnay, France (Not yet recruiting)
  • Cécile DUJON
• Pneumologie CH, Le Mans, France (Not yet recruiting)
  • Olivier MOLINIER
• Oncologie Centre Oscar Lombret, Lille, France (Not yet recruiting)
  • Eric DANSIN
• Pneumologie Hôpital Calmette, Lille, France (Not yet recruiting)
  • Alexis CORTOT
• Pneumologie CHU Limoges, Limoges, France (Not yet recruiting)
  • Yannick SIMONNEAU
• Hôpital du Scorff, Lorient, France (Recruiting)
  • Régine LAMY
  • Régine LAMY (Principal Investigator)
• Pneumologie Hôpital privé Jean Mermoz, Lyon, France (Not yet recruiting)
  • Pierre BOMBARON
• Centre Léon Bérard, Lyon, France (Recruiting)
  • Aurélie SWALDUZ
  • Aurélie SWALDUZ (Principal Investigator)
• Oncologie Hôpital François Quesnay, Mantes-la-Jolie, France (Not yet recruiting)
  • Karima SABOUNDJI
• Pneumologie Hôpital Européen, Marseille, France (Recruiting)
  • Jacques LE TREUT
• Oncologie Institut Paoli Calmette, Marseille, France (Not yet recruiting)
  • Anne MADROSZYK
• Hôpital Nord, Marseille, France (Recruiting)
  • Laurent GREILLIER
  • Laurent GREILLIER (Principal Investigator)
• Hôpital de Meaux, Meaux, France (Recruiting)
  • Chrystèle LOCHER, PhD
  • Chrystèle LOCHER, PhD (Principal Investigator)
• Oncologie Institut du Cancer de Montpellier, Montpellier, France (Not yet recruiting)
  • Camille TRAVERT
• Oncologie CH Morlaix, Morlaix, France (Not yet recruiting)
  • Karim AMRANE
• Pneumologie CHR, Orléans, France (Recruiting)
  • Hugues H MOREL
• Oncologie Institut Curie, Paris, France (Not yet recruiting)
  • Catherine DANIEL
• Pneumologie Centre Hospitalier, Pau, France (Recruiting)
  • Aldo RENAULT
• Hôpital du Haut Leveque, Pessac, France (Not yet recruiting)
  • Rémi VEILLON
  • Rémi VEILLON (Principal Investigator)
• CHU Pontchailloux, Rennes, France (Recruiting)
  • Charles RICORDEL, PhD
  • Charles RICORDEL, PhD (Principal Investigator)
• Hôpital Charles Nicolle, Rouen, France (Recruiting)
  • Florian GUISIER
  • Florian GUISIER (Principal Investigator)
• Pneumologie Hôpital Yves Le Foll, Saint-Brieuc, France (Not yet recruiting)
  • Gwenaelle LE GARFF
• CHU La Réunion Site Sud, Saint-Pierre, France (Recruiting)
  • Eric HUCHOT
• Institut Lucien Neuwirth, Saint-Priest-en-Jarez, France (Recruiting)
  • Pierre FOURNEL
  • Pierre FOURNEL (Principal Investigator)
• Centre Paul Strauss, Strasbourg, France (Not yet recruiting)
  • Roland SCHOTT, PhD
  • Roland SCHOTT, PhD (Principal Investigator)
• Pneumologie Hôpital Foch, Suresnes, France (Recruiting)
  • Hélène DOUBRE
• Pneumologie HIA, Talence, France (Not yet recruiting)
  • Jean-Michel PELONI
• Pneumologie Hôpital Sainte Musse, Toulon, France (Not yet recruiting)
  • Clarisse AUDIGIER VALETTE
• Hôpital d'Instruction des Armées Ste Anne, Toulon, France (Recruiting)
  • Olivier BYLICKI
  • Olivier BYLICKI (Principal Investigator)
• Hôpital Larrey, Toulouse, France (Not yet recruiting)
  • Laurence BIGAY-GAME
  • Laurence BIGAY-GAME (Principal Investigator)
• Oncologie CH Bretagne-Atlantique, Vannes, France (Recruiting)
  • Gonzague DE CHABOT
• Centre Hospitalier de Villefranche sur Saone, Villefranche-sur-Saône, France (Recruiting)
  • Lionel FALCHERO
  • Lionel FALCHERO (Principal Investigator)
• Oncologie Institut Gustave Roussy, Villejuif, France (Not yet recruiting)
  • Benjamin BESSE
• Pneumologie CHI, Villeneuve-Saint-Georges, France (Not yet recruiting)
  • Alexa MAIROVITZ

Study Officials

• Christos CHOUAID (Study Director) — Groupe Francais De Pneumo-Cancerologie