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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
RNAseq
Genetic1. 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Bioexalk cohortOther 1 intervention
Trial outcomes
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
Time frame
From date of treatment initiation up to 72 monthsSecondary outcomes
1
Overall Survival (OS)
OS defined as time from treatment initiation to death from any cause.
Time frame
From date of treatment initiation up to 72 months2
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.
Time frame
From date of treatment initiation up to 72 months3
Overall Response Rate (ORR)
ORR defined as objective response rate of complete response or partial response measured by local review RECIST v1.1.
Time frame
From date of treatment initiation up to 72 months4
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
Time frame
From date of treatment initiation up to 72 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Groupe Francais De Pneumo-Cancerologie
Lead sponsor
Takeda
Collaborator
Source ClinicalTrials.gov