Non-small Cell Lung CancerBIOEXALKNCT05122806
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
A study testing RNAseq in people with Non-small Cell Lung Cancer and ALK Gene Rearrangement Positive, run by Groupe Francais De Pneumo-Cancerologie at 46 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive
- What is being tested?
- RNAseq
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 46 sitesFrance
- Study dates
- 22 Sep 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who do not wish to participate in Bioexalk
- Patients under guardianship
Trial locations and contacts
46 sites in 1 country. Contact the study team or a site near you to ask about taking part.
46 sites in 1 country
France46 sites, 46 recruiting
- Not yet recruiting
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, 13616
Stéphanie MARTINEZ, +33 442335067, smartinez@ch-aix.fr
Stéphanie MARTINEZ
- Not yet recruiting
Pneumologie CHU
Amiens, 80054
Géraldine FRANCOIS, francois.geraldine@chu-amiens.fr
- Not yet recruiting
Centre Hospitalier Universitaire
Angers, 49033
Thierry URBAN, +33241355844, thurban@chu-angers.fr
Thierry URBAN
- Recruiting
Centre Hospitalier d'Annecy
Annecy, 74374
Chantal DECROISETTE, +33 450636603, cdecroisette@ch-annecygenevois.fr
Chantal H DECROISETTE
- Recruiting
Centre Hospitalier du Morvan
Brest, 29200
Renaud DESCOURT, PhD, +33 298223827, renaud.descourt@chu-brest.fr
Renaud DESCOURT, PhD
- Not yet recruiting
Centre François Baclesse
Caen, 14000
Radj GERVAIS, +33231455013, r.gervais@baclesse.fr
Radj GERVAIS
- Recruiting
Pneumologie CH Métropole Savoie
Chambéry, 73000
Julian PINSOLLE, julian.pinsolle@ch-metropole-savoie.fr
- Not yet recruiting
Oncologie CLCC Jean Perrin
Clermont-Ferrand, 63000
Lise THIBONNIER, lise.thibonnier@clermont.unicancer.fr
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Gaelle ROUSSEAU-BUSSAC, PhD, gaelle.rousseaubussac@chicreteil.fr
Gaelle ROUSSEAU-BUSSAC, PhD
- Recruiting
Pneumologie CH Eure-Seine
Évreux, 27000
Nicolas DELBERGHE, nicolas.delberghe@ch-eureseine.fr
- Recruiting
Pneumologie CHD Vendée
La Roche-sur-Yon, 85925
Marie MARCQ, marie-marcq@chd-vendee.fr
- Not yet recruiting
Pneumologie Hôpital Mignot
Le Chesnay, 78157
Cécile DUJON, cdujon@ch-versailles.fr
- Not yet recruiting
Pneumologie CH
Le Mans, 72000
Olivier MOLINIER, omolinier@ch-lemans.fr
- Not yet recruiting
Oncologie Centre Oscar Lombret
Lille, 59000
Eric DANSIN, e-dansin@o-lambret.fr
- Not yet recruiting
Pneumologie Hôpital Calmette
Lille, 59000
Alexis CORTOT, elexis.cortot@chru-lille.fr
- Not yet recruiting
Pneumologie CHU Limoges
Limoges, 87042
Yannick SIMONNEAU, +33555056268, yannick.simonneau@chu-limoges.fr
- Recruiting
Hôpital du Scorff
Lorient, 56100
Régine LAMY, +33 297069706, r.lamy@ch-bretagne-sud.fr
Régine LAMY
- Not yet recruiting
Pneumologie Hôpital privé Jean Mermoz
Lyon, 69085
Pierre BOMBARON, p.bombaron@orange.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Aurélie SWALDUZ, +33 469756217, aurelie.swalduz@lyon.unicancer.fr
Aurélie SWALDUZ
- Not yet recruiting
Oncologie Hôpital François Quesnay
Mantes-la-Jolie, 78200
Karima SABOUNDJI, karimasaboundji@gmail.com
- Recruiting
Pneumologie Hôpital Européen
Marseille, 130003
Jacques LE TREUT, j.letreut@hopital-europeen.fr
- Not yet recruiting
Oncologie Institut Paoli Calmette
Marseille, 13273
Anne MADROSZYK, madroszyka@ipc.unicancer.fr
- Recruiting
Hôpital Nord
Marseille, 13915
Laurent GREILLIER, +33 491965901, laurent.GREILLIER@ap-hm.fr
Laurent GREILLIER
- Recruiting
Hôpital de Meaux
Meaux, 77100
Chrystèle LOCHER, PhD, +33 164353856, chlocher@ghef.fr
Chrystèle LOCHER, PhD
- Not yet recruiting
Oncologie Institut du Cancer de Montpellier
Montpellier, 34298
Camille TRAVERT, camille.travert@icm.unicancer.fr
- Not yet recruiting
Oncologie CH Morlaix
Morlaix, 29600
Karim AMRANE, kamrane@ch-morlaix.fr
- Recruiting
Pneumologie CHR
Orléans, 45000
Hugues H MOREL, hugues.morel@chr-orleans.fr
- Not yet recruiting
Oncologie Institut Curie
Paris, 75005
Catherine DANIEL, catherine.daniel@curie.fr
- Recruiting
Pneumologie Centre Hospitalier
Pau, 64000
Aldo RENAULT, also.renault@ch-pau.fr
- Not yet recruiting
Hôpital du Haut Leveque
Pessac, 33604
Rémi VEILLON, +33 557656338, remi.veillon@chu-bordeaux.fr
Rémi VEILLON
- Recruiting
CHU Pontchailloux
Rennes, 35000
Charles RICORDEL, PhD, +33 299283738, charles.ricordel@chu-rennes.fr
Charles RICORDEL, PhD
- Recruiting
Hôpital Charles Nicolle
Rouen, 76031
Florian GUISIER, +33 232888079, florian.guisier@chu-rouen.fr
Florian GUISIER
- Not yet recruiting
Pneumologie Hôpital Yves Le Foll
Saint-Brieuc, 22000
Gwenaelle LE GARFF, gwenaelle.legarff@ch-stbrieuc.fr
- Recruiting
Pneumologie CHU Félix Guyon
Saint-Denis, La Réunion, 97400
Diane MOREAU, diane.moreau@chu-reunion.fr
- Recruiting
CHU La Réunion Site Sud
Saint-Pierre, 97410
Eric HUCHOT, eric.huchot@chr-reunion.fr
- Recruiting
Institut Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
Pierre FOURNEL, +33 477917036, pierre.fournel@icloire.fr
Pierre FOURNEL
- Not yet recruiting
Centre Paul Strauss
Strasbourg, 67065
Roland SCHOTT, PhD, +33 368766666, rschott@strasbourg@unicancer.fr
Roland SCHOTT, PhD
- Recruiting
Pneumologie Hôpital Foch
Suresnes, 92150
Hélène DOUBRE, h.doubre@hopital-foch.com
- Not yet recruiting
Pneumologie HIA
Talence, 33400
Jean-Michel PELONI, jm.peloni@mspb.com
- Not yet recruiting
Pneumologie Hôpital Sainte Musse
Toulon, 83056
Clarisse AUDIGIER VALETTE, clarisse.audigier-valette@ch-toulon.fr
- Recruiting
Hôpital d'Instruction des Armées Ste Anne
Toulon, 83800
Olivier BYLICKI, +33 483162937, bylicki.olivier@yahoo.fr
Olivier BYLICKI
- Not yet recruiting
Hôpital Larrey
Toulouse, 31059
Laurence BIGAY-GAME, +33 567771836, bigaygame.l@chu-toulouse.fr
Laurence BIGAY-GAME
- Recruiting
Oncologie CH Bretagne-Atlantique
Vannes, 56000
Gonzague DE CHABOT, gonzague.dechabot@ch-bretagne-atlantique.fr
- Recruiting
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, 69655
Lionel FALCHERO, +33 4 74 09 27 23, LFalchero@lhopitalnordouest.fr
Lionel FALCHERO
- Not yet recruiting
Oncologie Institut Gustave Roussy
Villejuif, 94805
Benjamin BESSE, benjamin.besse@gustaveroussy.fr
- Not yet recruiting
Pneumologie CHI
Villeneuve-Saint-Georges, 94195
Alexa MAIROVITZ, alexa.mairovitz@chiv.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- RNAseq
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNAseqGenetic
Also called DNA NGS
- 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
| Study group | Role | What they receive |
|---|---|---|
| Bioexalk cohort | Other | All patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk. Receives: Genetic: RNAseq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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
Measured: From date of treatment initiation up to 72 months
Secondary outcomes (11)
Overall Survival (OS)
OS defined as time from treatment initiation to death from any cause.
Measured: From date of treatment initiation up to 72 months
Duration of Response (DoR)
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.
Measured: From date of treatment initiation up to 72 months
Overall Response Rate (ORR)
ORR defined as objective response rate of complete response or partial response measured by local review RECIST v1.1.
Measured: 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
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Measured: 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
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Measured: 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
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Measured: 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
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Measured: From date of treatment initiation up to 72 months
Description of mechanisms of resistance associated with first-line tyrosine kinase inhibitors
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
Measured: From date of treatment initiation up to 72 months
Description of mechanism of resistance associated with each ALK-fusion partner
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
Measured: From date of treatment initiation up to 72 months
Concordance between ALK fusion partner and co-mutations
ALK fusion partner and co-mutation identifications based on liquid and tissue biopsies at Baseline
Measured: From date of treatment initiation up to 72 months
Impact of presence or absence of serum Anti-ALK antibodies at diagnosis on OS
Measured: From date of treatment initiation up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start22 Sep 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Christos CHOUAID, Study director, Groupe Francais De Pneumo-Cancerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122806
- Sponsor's protocol ID
- GroupeFDPC
- Other IDs
- GFPC 08-2020
- Acronym
- BIOEXALK
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study
- ClinicalTrials.gov ID
- NCT05122806
- Acronym / sponsor ID
- BIOEXALK / GroupeFDPC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioexalk cohort | Other | Genetic: RNAseqAll patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not wish to participate in Bioexalk
- Patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNAseqAlso: DNA NGS1. 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 | Genetic | Bioexalk cohort |
Primary outcome
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
11 secondary outcomes
Overall Survival (OS)
Time frame: From date of treatment initiation up to 72 months
Duration of Response (DoR)
Time frame: From date of treatment initiation up to 72 months
Overall Response Rate (ORR)
Time frame: 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
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
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
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
Description of mechanisms of resistance associated with first-line tyrosine kinase inhibitors
Time frame: 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
Concordance between ALK fusion partner and co-mutations
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christos CHOUAID study director
Groupe Francais De Pneumo-Cancerologie
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RNAseq in people with Non-small Cell Lung Cancer and ALK Gene Rearrangement Positive, run by Groupe Francais De Pneumo-Cancerologie at 46 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian GUISIER (+33 2 32888079, florian.guisier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From date of treatment initiation up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.