Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 92
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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 (GFPC 03-2019).
Explore ALK GFPC 03-2019 is a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients, whose RCB reference is 2020-A00771-38 and which obtained an approval from the IDF II Ethic Committee on 25/05/2020. Biological analysis will be performed on tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA) on three timepoints (diagnosis, at first tumor evaluation and at the time of disease progression).
- 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..
- ctDNA : NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples (30mL on EDTA or STRECKs tubes) at diagnosis, at the time of the first evaluation and at the time of progression).
For plasma testing, after obtained patient consent, blood samples (35mL on EDTA or STRECKs tubes) at diagnosis, at the first evaluation and at disease progression will be taken.
The ALKis include alectinib and brigatinib as first-line therapy or other drugs with marketing authorizations (lorlatinib, entrectinib) or in early access programs (EAPs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who do not wish to participate in Bioexalk
- •Patients under guardianship
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of treatment initiation up to 72 months
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
次要结局
- Circulating tumoral DNA (ctDNA) clearance on Overall Survival (OS) of stage IV ALK-rearranged NSCLC patients(From date of treatment initiation up to 72 months)
- Circulating tumoral DNA (ctDNA) clearance on Duration of Response (DoR) of stage IV ALK-rearranged NSCLC patients(From date of treatment initiation up to 72 months)
- Description of mechanism of resistance associated with each ALK-fusion partner(From date of treatment initiation up to 72 months)
- Overall Response Rate (ORR)(From date of treatment initiation up to 72 months)
- Overall Survival (OS)(From date of treatment initiation up to 72 months)
- Impact of presence or absence of serum Anti-ALK antibodies at diagnosis on OS(From date of treatment initiation up to 72 months)
- Circulating tumoral DNA (ctDNA) clearance on Progression Free Survival (PFS) of stage IV ALK-rearranged NSCLC patients(From date of treatment initiation up to 72 months)
- Duration of Response (DoR)(From date of treatment initiation up to 72 months)
- Description of mechanisms of resistance associated with first-line tyrosine kinase inhibitors(From date of treatment initiation up to 72 months)
- Circulating tumoral DNA (ctDNA) clearance on Overall Response Rate (ORR) of stage IV ALK-rearranged NSCLC patients(From date of treatment initiation up to 72 months)
- Concordance between ALK fusion partner and co-mutations(From date of treatment initiation up to 72 months)