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
- Are there results?
- None posted in the registry
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- early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT06234579
- Acronym / sponsor ID
- GALILEO / 4906
- Conditions
- ALK Gene Mutation, NSCLC Stage IV, ALK Sensitizing Mutation
- Keywords
- ALK mutation, NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALK+ NSCLC | – | Diagnostic Test: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy (tissue or liquid)Also: Alectinib, Brigatinib, LorlatinibAt 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. | Diagnostic test | ALK+ NSCLC |
Primary outcome
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
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
2 secondary outcomes
PFS to first-line treatment with II-III generation ALK-inhibitor
Time frame: 5 years
PFS to first-line treatment with II-III generation ALK-inhibitor
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GIAMPAOLO TORTORA, Prof. principal investigator
Fondazione Policlinico Universitario A Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALK Gene Mutation and NSCLC Stage IV, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Vita, MD (3480510228, dr.emanuele.vita@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with available NGS testing at diagnosis (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.