Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Francais De Pneumo-Cancerologie
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients who do not wish to participate in Bioexalk
Patients under guardianship
Trial design
Treatments tested in this trial
- RNAseq
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Groupe Francais De Pneumo-Cancerologie
Lead sponsor
Takeda
Collaborator
Source ClinicalTrials.gov