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

Recruiting

• Conditions: ALK Gene Mutation; NSCLC Stage IV; ALK Sensitizing Mutation
• Interventions: Diagnostic Test: Biopsy (tissue or liquid)

• Registration Number: NCT06234579
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2026-03-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALK+ NSCLC	Biopsy (tissue or liquid)	The GALILEO project is an Italian observational prospective cohort study on advanced ALK+ NSCLC patient progressing on first-line therapy with alectinib

Primary Outcome Measures

Name	Time	Method
Percentage of patients with available NGS testing at diagnosis	5 years	Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy
Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor	5 years	Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy

Secondary Outcome Measures

Name	Time	Method
PFS to first-line treatment with II-III generation ALK-inhibitor	5 years	Time from treatment start to death for any cause, assesed up to 5 years

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Italy