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Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)

Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)

Recruiting
18 years and older
All
Phase N/A

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Overview

The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.

Eligibility

Inclusion Criteria:

  • a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available) b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days c) ECOG PS 0-2 d) adult patients (aged ≥ 18 years) at the moment of diagnosis e) signing of informed consent approved by the local Ethic Committee

Exclusion Criteria:

  1. Diagnosis of lung cancer without ALK rearrangement
  2. early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Study details
    ALK Gene Mutation
    NSCLC Stage IV
    ALK Sensitizing Mutation

NCT06234579

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

16 February 2024

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