Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC (BIOEXALK)

April 24, 2026 updated by: Groupe Francais De Pneumo-Cancerologie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with new generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019).

Explore ALK GFPC 03-2019 is a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients, whose RCB reference is 2020-A00771-38 and which obtained an approval from the IDF II Ethic Committee on 25/05/2020. Biological analysis will be performed on tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA) on three timepoints (diagnosis, at first tumor evaluation and at the time of disease progression).

  • 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..
  • ctDNA : NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples (30mL on EDTA or STRECKs tubes) at diagnosis, at the time of the first evaluation and at the time of progression).

For plasma testing, after obtained patient consent, blood samples (35mL on EDTA or STRECKs tubes) at diagnosis, at the first evaluation and at disease progression will be taken.

The ALKis include alectinib and brigatinib as first-line therapy or other drugs with marketing authorizations (lorlatinib, entrectinib) or in early access programs (EAPs).

Liquid biopsies will be analyzed with a NGS panel allowing the identification of ALK fusion partners and resistance mechanisms (mutations, fusions, copy number variations). Samples will be sent for centralized analysis to the Léon Bérard Center (Lyon).

For biological analysis on tissue obtained at diagnosis, the ALK fusion partner and its variant will be identified by RNAseq. Whenever a tissue re-biopsy is performed at the time of disease progression as part of the standard of care management of the patient, the remaining tissue sample will be collected as part of the BioExALK study, so that RNAseq analysis will be performed to look for resistance mechanisms. Tissue samples (10 slides of 5 microns) will be sent for centralized analysis to the Rouen University Hospital.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13616
        • Not yet recruiting
        • Centre Hospitalier d'Aix en Provence
        • Principal Investigator:
          • Stéphanie MARTINEZ
        • Contact:
      • Amiens, France, 80054
      • Angers, France, 49033
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Thierry URBAN
      • Annecy, France, 74374
        • Recruiting
        • Centre Hospitalier d'Annecy
        • Principal Investigator:
          • Chantal H DECROISETTE
        • Contact:
      • Brest, France, 29200
        • Recruiting
        • Centre Hospitalier du Morvan
        • Contact:
        • Principal Investigator:
          • Renaud DESCOURT, PhD
      • Caen, France, 14000
        • Not yet recruiting
        • Centre Francois Baclesse
        • Contact:
        • Principal Investigator:
          • Radj GERVAIS
      • Chambéry, France, 73000
      • Clermont-Ferrand, France, 63000
      • Créteil, France, 94010
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:
        • Principal Investigator:
          • Gaelle ROUSSEAU-BUSSAC, PhD
      • La Roche-sur-Yon, France, 85925
      • Le Chesnay, France, 78157
      • Le Mans, France, 72000
      • Lille, France, 59000
      • Lille, France, 59000
      • Limoges, France, 87042
      • Lorient, France, 56100
        • Recruiting
        • Hôpital du Scorff
        • Principal Investigator:
          • Régine Lamy
        • Contact:
      • Lyon, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Contact:
        • Principal Investigator:
          • Aurélie SWALDUZ
      • Lyon, France, 69085
        • Not yet recruiting
        • Pneumologie Hôpital privé Jean Mermoz
        • Contact:
      • Mantes-la-Jolie, France, 78200
      • Marseille, France, 13273
      • Marseille, France, 13915
        • Recruiting
        • Hopital Nord
        • Principal Investigator:
          • Laurent GREILLIER
        • Contact:
      • Marseille, France, 130003
      • Meaux, France, 77100
        • Recruiting
        • Hôpital de Meaux
        • Contact:
        • Principal Investigator:
          • Chrystèle LOCHER, PhD
      • Montpellier, France, 34298
      • Morlaix, France, 29600
      • Orléans, France, 45000
      • Paris, France, 75005
      • Pau, France, 64000
      • Pessac, France, 33604
        • Not yet recruiting
        • Hôpital du Haut Lévêque
        • Principal Investigator:
          • Remi Veillon
        • Contact:
      • Rennes, France, 35000
        • Recruiting
        • CHU Pontchailloux
        • Contact:
        • Principal Investigator:
          • Charles RICORDEL, PhD
      • Rouen, France, 76031
        • Recruiting
        • Hôpital Charles Nicolle
        • Principal Investigator:
          • Florian GUISIER
        • Contact:
      • Saint-Brieuc, France, 22000
      • Saint-Pierre, France, 97410
      • Saint-Priest-en-Jarez, France, 42271
        • Recruiting
        • Institut Lucien Neuwirth
        • Principal Investigator:
          • Pierre FOURNEL
        • Contact:
      • Strasbourg, France, 67065
        • Not yet recruiting
        • Centre Paul Strauss
        • Contact:
        • Principal Investigator:
          • Roland SCHOTT, PhD
      • Suresnes, France, 92150
      • Talence, France, 33400
        • Not yet recruiting
        • Pneumologie HIA
        • Contact:
      • Toulon, France, 83056
      • Toulon, France, 83800
        • Recruiting
        • Hôpital d'Instruction des Armées Ste Anne
        • Contact:
        • Principal Investigator:
          • Olivier BYLICKI
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hopital Larrey
        • Principal Investigator:
          • Laurence BIGAY-GAME
        • Contact:
      • Vannes, France, 56000
      • Villefranche-sur-Saône, France, 69655
        • Recruiting
        • Centre Hospitalier de Villefranche sur Saone
        • Contact:
        • Principal Investigator:
          • Lionel FALCHERO
      • Villejuif, France, 94805
      • Villeneuve-Saint-Georges, France, 94195
      • Évreux, France, 27000
    • La Réunion
      • Saint-Denis, La Réunion, France, 97400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bioexalk cohort
All patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk.
Genetic: RNAseq
  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
Other Names:
  • DNA NGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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
From date of treatment initiation up to 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of treatment initiation up to 72 months
OS defined as time from treatment initiation to death from any cause.
From date of treatment initiation up to 72 months
Duration of Response (DoR)
Time Frame: From date of treatment initiation up to 72 months
DoR assessed by local review using RECIST v1.1, defined as time from treatment initiation to the first clinical or radiological progression, death, consent withdrawn, adverse event, protocol deviations, lost to follow-up, or initiation of a new line of anticancer therapy.
From date of treatment initiation up to 72 months
Overall Response Rate (ORR)
Time Frame: From date of treatment initiation up to 72 months
ORR defined as objective response rate of complete response or partial response measured by local review RECIST v1.1.
From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Progression Free Survival (PFS) of stage IV ALK-rearranged NSCLC patients
Time Frame: From date of treatment initiation up to 72 months
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Overall Survival (OS) of stage IV ALK-rearranged NSCLC patients
Time Frame: From date of treatment initiation up to 72 months
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Duration of Response (DoR) of stage IV ALK-rearranged NSCLC patients
Time Frame: From date of treatment initiation up to 72 months
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Overall Response Rate (ORR) of stage IV ALK-rearranged NSCLC patients
Time Frame: From date of treatment initiation up to 72 months
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
From date of treatment initiation up to 72 months
Description of mechanisms of resistance associated with first-line tyrosine kinase inhibitors
Time Frame: From date of treatment initiation up to 72 months
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
From date of treatment initiation up to 72 months
Description of mechanism of resistance associated with each ALK-fusion partner
Time Frame: From date of treatment initiation up to 72 months
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
From date of treatment initiation up to 72 months
Concordance between ALK fusion partner and co-mutations
Time Frame: From date of treatment initiation up to 72 months
ALK fusion partner and co-mutation identifications based on liquid and tissue biopsies at Baseline
From date of treatment initiation up to 72 months
Impact of presence or absence of serum Anti-ALK antibodies at diagnosis on OS
Time Frame: From date of treatment initiation up to 72 months
From date of treatment initiation up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francais De Pneumo-Cancerologie

Collaborators

Takeda

Investigators

  • Study Director: Christos CHOUAID, Groupe Francais De Pneumo-Cancerologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GroupeFDPC
  • GFPC 08-2020 (Other Identifier: GroupeFDPC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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