Clinical trial Recruiting at 22 sites Interventional Ages 18 and up

Analyzing biological characteristics of advanced ALK-rearranged lung cancer

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

Run by Groupe Francais De Pneumo-Cancerologie · NCT05122806 · Data updated 2026-11-12

This study is trying to understand the biological features of advanced lung cancer with ALK gene changes in patients who are starting treatment with new targeted medications.

More Non-Small Cell Lung Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorGroupe Francais De Pneumo-Cancerologie
Academic / other
Drugs / interventionsalectinib, brigatinib, lorlatinib, entrectinib
Locations46 sites (Saint-Denis, La Réunion and 45 other locations)
StatusRecruiting
StartedSeptember 22, 2021
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedApril 29, 2026
Trial IDNCT05122806 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with stage IIIB/IV NSCLC that is not eligible for curative locoregional treatment and confirmed ALK rearrangement.

Probably not a fit

Patients who do not wish to participate in the BioEXALK study or are under guardianship will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BioEXALK is a prospective study that evaluates the biological characteristics of advanced non-small cell lung cancer (NSCLC) with ALK gene rearrangements, focusing on patients treated with next-generation tyrosine kinase inhibitors (TKIs) in the first line. The study is part of the national EXPLORE ALK cohort and involves collecting tumor tissue and circulating tumor DNA (ctDNA) at diagnosis, during the first tumor evaluation, and at disease progression. Biological analyses will be performed using RNA sequencing on tumor biopsies and next-generation sequencing on blood samples to identify ALK fusion partners and associated mutations.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of the biological mechanisms underlying advanced ALK-rearranged NSCLC, potentially improving treatment strategies.

How similar studies have gone: Other studies have shown success in analyzing biological characteristics of lung cancer, but this specific approach focusing on ALK-rearranged NSCLC with next-generation TKIs is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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's running

  • Pneumologie CHU Félix Guyon
    Saint-Denis, La Réunion, France
    Recruiting
  • Centre Hospitalier d'Annecy
    Annecy, France
    Recruiting
  • Centre Hospitalier du Morvan
    Brest, France
    Recruiting
  • Pneumologie CH Métropole Savoie
    Chambéry, France
    Recruiting
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, France
    Recruiting
  • Pneumologie CH Eure-Seine
    Évreux, France
    Recruiting
Show 40 more locations
  • Pneumologie CHD Vendée
    La Roche-sur-Yon, France
    Recruiting
  • Hôpital du Scorff
    Lorient, France
    Recruiting
  • Centre Léon Bérard
    Lyon, France
    Recruiting
  • Pneumologie Hôpital Européen
    Marseille, France
    Recruiting
  • Hôpital Nord
    Marseille, France
    Recruiting
  • Hôpital de Meaux
    Meaux, France
    Recruiting
  • Pneumologie CHR
    Orléans, France
    Recruiting
  • Pneumologie Centre Hospitalier
    Pau, France
    Recruiting
  • CHU Pontchailloux
    Rennes, France
    Recruiting
  • Hôpital Charles Nicolle
    Rouen, France
    Recruiting
  • CHU La Réunion Site Sud
    Saint-Pierre, France
    Recruiting
  • Institut Lucien Neuwirth
    Saint-Priest-en-Jarez, France
    Recruiting
  • Pneumologie Hôpital Foch
    Suresnes, France
    Recruiting
  • Hôpital d'Instruction des Armées Ste Anne
    Toulon, France
    Recruiting
  • Oncologie CH Bretagne-Atlantique
    Vannes, France
    Recruiting
  • Centre Hospitalier de Villefranche sur Saone
    Villefranche-sur-Saône, France
    Recruiting
  • Centre Hospitalier d'Aix en Provence
    Aix-en-Provence, France
    Not yet recruiting
  • Pneumologie CHU
    Amiens, France
    Not yet recruiting
  • Centre Hospitalier Universitaire
    Angers, France
    Not yet recruiting
  • Centre François Baclesse
    Caen, France
    Not yet recruiting
  • Oncologie CLCC Jean Perrin
    Clermont-Ferrand, France
    Not yet recruiting
  • Pneumologie Hôpital Mignot
    Le Chesnay, France
    Not yet recruiting
  • Pneumologie CH
    Le Mans, France
    Not yet recruiting
  • Oncologie Centre Oscar Lombret
    Lille, France
    Not yet recruiting
  • Pneumologie Hôpital Calmette
    Lille, France
    Not yet recruiting
  • Pneumologie CHU Limoges
    Limoges, France
    Not yet recruiting
  • Pneumologie Hôpital privé Jean Mermoz
    Lyon, France
    Not yet recruiting
  • Oncologie Hôpital François Quesnay
    Mantes-la-Jolie, France
    Not yet recruiting
  • Oncologie Institut Paoli Calmette
    Marseille, France
    Not yet recruiting
  • Oncologie Institut du Cancer de Montpellier
    Montpellier, France
    Not yet recruiting
  • Oncologie CH Morlaix
    Morlaix, France
    Not yet recruiting
  • Oncologie Institut Curie
    Paris, France
    Not yet recruiting
  • Hôpital du Haut Leveque
    Pessac, France
    Not yet recruiting
  • Pneumologie Hôpital Yves Le Foll
    Saint-Brieuc, France
    Not yet recruiting
  • Centre Paul Strauss
    Strasbourg, France
    Not yet recruiting
  • Pneumologie HIA
    Talence, France
    Not yet recruiting
  • Pneumologie Hôpital Sainte Musse
    Toulon, France
    Not yet recruiting
  • Hôpital Larrey
    Toulouse, France
    Not yet recruiting
  • Oncologie Institut Gustave Roussy
    Villejuif, France
    Not yet recruiting
  • Pneumologie CHI
    Villeneuve-Saint-Georges, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.