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

Last updated: July 29, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Biopsy (tissue or liquid)

Clinical Study ID

NCT06234579
4906
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangementdetection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can beincluded if adequate tissue for NGS is available) b) to have received upfront treatment with alectinib, brigatinib or lorlatinib forat 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

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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: Biopsy (tissue or liquid)
Phase:
Study Start date:
July 12, 2021
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Fondazione Policlinico Gemelli IRCCS

    Rome, 00168
    Italy

    Active - Recruiting

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