Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
BIOEXALK
Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study
2 other identifiers
interventional
100
1 country
46
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
Started Sep 2021
Longer than P75 for not_applicable nonsmall-cell-lung-cancer
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2021
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 29, 2026
April 1, 2026
5.8 years
September 6, 2021
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
From date of treatment initiation up to 72 months
Secondary Outcomes (11)
Overall Survival (OS)
From date of treatment initiation up to 72 months
Duration of Response (DoR)
From date of treatment initiation up to 72 months
Overall Response Rate (ORR)
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
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
From date of treatment initiation up to 72 months
- +6 more secondary outcomes
Study Arms (1)
Bioexalk cohort
OTHERAll patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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 enrolled in the french National Health Insurance program or with a third- party payer
You may not qualify if:
- Patients who do not wish to participate in Bioexalk
- Patients under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupe Francais De Pneumo-Cancerologielead
- Takedacollaborator
Study Sites (46)
Pneumologie CHU Félix Guyon
Saint-Denis, La Réunion, 97400, France
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, 13616, France
Pneumologie CHU
Amiens, 80054, France
Centre Hospitalier Universitaire
Angers, 49033, France
Centre Hospitalier d'Annecy
Annecy, 74374, France
Centre Hospitalier du Morvan
Brest, 29200, France
Centre François Baclesse
Caen, 14000, France
Pneumologie CH Métropole Savoie
Chambéry, 73000, France
Oncologie CLCC Jean Perrin
Clermont-Ferrand, 63000, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Pneumologie CH Eure-Seine
Évreux, 27000, France
Pneumologie CHD Vendée
La Roche-sur-Yon, 85925, France
Pneumologie Hôpital Mignot
Le Chesnay, 78157, France
Pneumologie CH
Le Mans, 72000, France
Oncologie Centre Oscar Lombret
Lille, 59000, France
Pneumologie Hôpital Calmette
Lille, 59000, France
Pneumologie CHU Limoges
Limoges, 87042, France
Hôpital du Scorff
Lorient, 56100, France
Pneumologie Hôpital privé Jean Mermoz
Lyon, 69085, France
Centre Léon Bérard
Lyon, 69373, France
Oncologie Hôpital François Quesnay
Mantes-la-Jolie, 78200, France
Pneumologie Hôpital Européen
Marseille, 130003, France
Oncologie Institut Paoli Calmette
Marseille, 13273, France
Hôpital Nord
Marseille, 13915, France
Hôpital de Meaux
Meaux, 77100, France
Oncologie Institut du Cancer de Montpellier
Montpellier, 34298, France
Oncologie CH Morlaix
Morlaix, 29600, France
Pneumologie CHR
Orléans, 45000, France
Oncologie Institut Curie
Paris, 75005, France
Pneumologie Centre Hospitalier
Pau, 64000, France
Hôpital du Haut Leveque
Pessac, 33604, France
CHU Pontchailloux
Rennes, 35000, France
Hôpital Charles Nicolle
Rouen, 76031, France
Pneumologie Hôpital Yves Le Foll
Saint-Brieuc, 22000, France
CHU La Réunion Site Sud
Saint-Pierre, 97410, France
Institut Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Centre Paul Strauss
Strasbourg, 67065, France
Pneumologie Hôpital Foch
Suresnes, 92150, France
Pneumologie HIA
Talence, 33400, France
Pneumologie Hôpital Sainte Musse
Toulon, 83056, France
Hôpital d'Instruction des Armées Ste Anne
Toulon, 83800, France
Hôpital Larrey
Toulouse, 31059, France
Oncologie CH Bretagne-Atlantique
Vannes, 56000, France
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, 69655, France
Oncologie Institut Gustave Roussy
Villejuif, 94805, France
Pneumologie CHI
Villeneuve-Saint-Georges, 94195, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christos CHOUAID
Groupe Francais De Pneumo-Cancerologie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2021
First Posted
November 17, 2021
Study Start
September 22, 2021
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share