ALK Gene MutationGALILEONCT06234579
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)
An observational study of ALK Gene Mutation and NSCLC Stage IV, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK Gene Mutation, NSCLC Stage IV, ALK Sensitizing Mutation
- What is being tested?
- Biopsy (tissue or liquid)
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2021to 31 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed ALK+ NSCLC who are candidate to receive first-line therapy with II-III genaration ALK-inhibitor (alectinib, brigatinib or lorlatinib)
Who may be able to join
- 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)
- to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days
- ECOG PS 0-2
- adult patients (aged ≥ 18 years) at the moment of diagnosis
- signing of informed consent approved by the local Ethic Committee
Who cannot join
- Diagnosis of lung cancer without ALK rearrangement
- early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, 00168
Emilio Bria, Professor, 0630155202 ext. +39, emilio.bria@policlinicogemelli.it
About this study
Official 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".
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.
- Conditions
- ALK Gene Mutation, NSCLC Stage IV, ALK Sensitizing Mutation
- Being tested
- Biopsy (tissue or liquid)
- Keywords
- ALK mutation, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy (tissue or liquid)Diagnostic test
Also called Alectinib, Brigatinib, Lorlatinib
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.
| Study group | Role | What they receive |
|---|---|---|
| ALK+ NSCLC | The GALILEO project is an Italian observational prospective cohort study on advanced ALK+ NSCLC patient progressing on first-line therapy with alectinib Receives: Diagnostic Test: Biopsy (tissue or liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with available NGS testing at diagnosis
Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy
Measured: 5 years
Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor
Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy
Measured: 5 years
Secondary outcomes (2)
PFS to first-line treatment with II-III generation ALK-inhibitor
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
Measured: 5 years
PFS to first-line treatment with II-III generation ALK-inhibitor
Time from treatment start to death for any cause, assesed up to 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start12 Jul 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bria Emilio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- GIAMPAOLO TORTORA, Prof., Principal investigator, Fondazione Policlinico Universitario A Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234579
- Sponsor's protocol ID
- 4906
- Acronym
- GALILEO
- Status last verified
- Jul 2024
- First submitted
- 10 Apr 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No