Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Recruiting now · Not applicable
Conditions studied: Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive
In brief
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.
Key facts
- Study ID
- NCT05122806
- Run by
- Groupe Francais De Pneumo-Cancerologie
- People needed
- 100
- Starts
- 2021-09-22
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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 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
You may not qualify if…
- Patients who do not wish to participate in Bioexalk
- Patients under guardianship
Where it is running
- Pneumologie CH Eure-Seine — Évreux, France (enrolling)
- Centre Hospitalier d'Annecy — Annecy, France (enrolling)
- Centre Hospitalier du Morvan — Brest, France (enrolling)
- Pneumologie CH Métropole Savoie — Chambéry, France (enrolling)
- Centre Hospitalier Intercommunal de Créteil — Créteil, France (enrolling)
- Pneumologie CHU Félix Guyon — Saint-Denis, La Réunion, France (enrolling)
- Pneumologie CHD Vendée — La Roche-sur-Yon, France (enrolling)
- Hôpital du Scorff — Lorient, France (enrolling)
- Centre Léon Bérard — Lyon, France (enrolling)
- Pneumologie Hôpital Européen — Marseille, France (enrolling)
- Hôpital Nord — Marseille, France (enrolling)
- Hôpital de Meaux — Meaux, France (enrolling)
- Pneumologie CHR — Orléans, France (enrolling)
- Pneumologie Centre Hospitalier — Pau, France (enrolling)
- CHU Pontchailloux — Rennes, France (enrolling)
- Hôpital Charles Nicolle — Rouen, France (enrolling)
- CHU La Réunion Site Sud — Saint-Pierre, France (enrolling)
- Institut Lucien Neuwirth — Saint-Priest-en-Jarez, France (enrolling)
- Pneumologie Hôpital Foch — Suresnes, France (enrolling)
- Hôpital d'Instruction des Armées Ste Anne — Toulon, France (enrolling)
- Oncologie CH Bretagne-Atlantique — Vannes, France (enrolling)
- Centre Hospitalier de Villefranche sur Saone — Villefranche-sur-Saône, France (enrolling)
- Oncologie Institut Paoli Calmette — Marseille, France
- Pneumologie CHI — Villeneuve-Saint-Georges, France
- Hôpital Larrey — Toulouse, France
Full record on ClinicalTrials.gov
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