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Analyzing biological characteristics of advanced ALK-rearranged lung cancer

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

NA · Groupe Francais De Pneumo-Cancerologie · NCT05122806

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

PhaseNA
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorGroupe Francais De Pneumo-Cancerologie (other)
Drugs / interventionsalectinib, brigatinib, lorlatinib, entrectinib
Locations46 sites (Saint-Denis, La Réunion and 45 other locations)
Trial IDNCT05122806 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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 performed: 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.

Eligibility criteria

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 this trial is running

Saint-Denis, La Réunion and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive

Last reviewed 2026-05-15 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.