NCT05122806 Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

Trial Parameters

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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

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