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

  • STATUS
    Recruiting
  • days left to enroll
    81
  • participants needed
    108
  • sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Updated on 13 August 2025
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Summary

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.

Details
Condition ALK Gene Mutation, NSCLC Stage IV, ALK Sensitizing Mutation
Age 18years or above
Clinical Study IdentifierNCT06234579
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last Modified on13 August 2025

Eligibility

 Yes No Not Sure

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

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a) early withdrawn of treatment due to toxicity without evidence of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