Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

Condition(s) studied

Investigational drug(s) / intervention(s)

RNAseq: 1. 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. 2. ctDNA : NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples

Study 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

Primary outcome measure(s)

• Progression Free Survival (PFS) — 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

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.

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