Status:
RECRUITING
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Lead Sponsor:
Groupe Francais De Pneumo-Cancerologie
Collaborating Sponsors:
Takeda
Conditions:
Non-small Cell Lung Cancer
ALK Gene Rearrangement Positive
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with new generation TKIs in first line, included in the national EXPLORE ALK cohort (...
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
Key Trial Info
Start Date :
September 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05122806
Start Date
September 22 2021
End Date
June 30 2027
Last Update
August 6 2025
Active Locations (46)
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1
Pneumologie CHU Félix Guyon
Saint-Denis, La Réunion, France, 97400
2
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France, 13616
3
Pneumologie CHU
Amiens, France, 80054
4
Centre Hospitalier Universitaire
Angers, France, 49033