NCT05122806 Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
| NCT ID | NCT05122806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Francais De Pneumo-Cancerologie |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-09-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients who do not wish to participate in Bioexalk * Patients under guardianship
Contact & Investigator
Christos CHOUAID
STUDY DIRECTOR
Groupe Francais De Pneumo-Cancerologie
Frequently Asked Questions
Who can join the NCT05122806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05122806 currently recruiting?
Yes, NCT05122806 is actively recruiting participants. Contact the research team at florian.guisier@chu-rouen.fr for enrollment information.
Where is the NCT05122806 trial being conducted?
This trial is being conducted at Saint-Denis, France, Aix-en-Provence, France, Amiens, France, Angers, France and 11 additional locations.
Who is sponsoring the NCT05122806 clinical trial?
NCT05122806 is sponsored by Groupe Francais De Pneumo-Cancerologie. The principal investigator is Christos CHOUAID at Groupe Francais De Pneumo-Cancerologie. The trial plans to enroll 100 participants.
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