Clinical trial · Interventional
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK Gene Rearrangement Positive | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RNAseq | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bioexalk cohort
- description
- All patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk.
- interventionNames
- Genetic: RNAseq
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From date of treatment initiation up to 72 months
- description
- 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
Secondary outcomes (11)
- measure
- Overall Survival (OS)
- timeFrame
- From date of treatment initiation up to 72 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available