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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Groupe Francais De Pneumo-Cancerologie Academic / other |
| Drugs / interventions | alectinib, brigatinib, lorlatinib, entrectinib |
| Locations | 46 sites (Saint-Denis, La Réunion and 45 other locations) |
| Status | Recruiting |
| Started | September 22, 2021 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT05122806 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
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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
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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
- Study coordinator: Florian GUISIER
- Email: florian.guisier@chu-rouen.fr
- Phone: +33 2 32888079
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.