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

Plain-language summary

This study aims to track the genetic changes in the tumor and how they evolve over time using tissue or blood biopsies in patients with advanced non-small cell lung cancer harboring an ALK rearrangement. It enrolls patients aged 18 and older who have received at least 28 days of treatment with alectinib, brigatinib, or lorlatinib. The study does not use a phase designation and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Intervention

Biopsy (tissue or liquid)

Start date

7/12/2021

Estimated completion

7/31/2026

Countries

Italy

Related genes

Locations

• Rome, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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:

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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study