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NCT Number: NCT06234579

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

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.

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Key information

Conditions

ALK Gene Mutation ALK Sensitizing Mutation Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Stage IV Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Emilio Bria, Professor

CONTACT

[email protected]

0630155202 ext. +39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Treatment and study plan

Biopsy (tissue or liquid)

Diagnostic Test

At the time of diagnosis, all newly diagnosed ALK+ NSCLC patients eligible for first line treatment with alectinib or brigatinib or lorlatinib will be considered for the study.

In case of progression, a multidisciplinary team (oncologists, interventional pneumologists and radiologists, surgeons) will discuss case-by-case the feasibility to procure an adequate biopsy from progressing lesions. Repeat biopsies will be performed within 2 weeks from multidisciplinary evaluation and before the start of subsequent treatment. If repeat biopsies are not technically or safely feasible or fail to yield sufficient material for genomic analysis, we will collect a whole blood drawn by venepuncture for the analysis of ctDNA.

Other names: Alectinib, Brigatinib, Lorlatinib

Primary outcomes

  1. Percentage of patients with available NGS testing at diagnosis

    Time frame: 5 years

    Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy

  2. Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor

    Time frame: 5 years

    Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy

Secondary outcomes

  1. PFS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: 5 years

    Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

  2. PFS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: 5 years

    Time from treatment start to death for any cause, assesed up to 5 years

Other outcomes

  1. PFS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

    PFS to first-line, stratified according to ALK-rearrangement variants

  2. PFS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

    PFS to first-line, stratified according to NGS-based mutational profiling

  3. OS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: Time from treatment start until the date of death from any cause, assessed up to 5 years

    OS to first-line, stratified according to ALK-rearrangement variants

  4. OS to first-line treatment with II-III generation ALK-inhibitor

    Time frame: Time from treatment start until the date of death from any cause, assessed up to 5 years

    OS to first-line, stratified according to NGS-based mutation profiling

  5. Incidence of secondary resistance mutations (SNVs) after first line treatment

    Time frame: 5 years

    Percentage of patients with SNV-based resistance diagnosed by tissue or liquid biopsy

  6. PFS to lorlatinib according to secondary resistance mechanism

    Time frame: Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

    PFS to second-line lorlatinib, stratified according to type of resistance (SNV vs off-target)

Study contacts

Contact information is provided by the study sponsor or research team.

EMILIO Bria, Prof.

CONTACT

[email protected]

0630156318

Emanuele Vita, MD

CONTACT

[email protected]

3480510228

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate".

Acronym: GALILEO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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