NCT06234579 Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)
| NCT ID | NCT06234579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | ALK Gene Mutation |
| Study Type | OBSERVATIONAL |
| Enrollment | 108 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 108 participants in total. It began in 2021-07-12 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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by the local Ethic Committee Exclusion Criteria: a) Diagnosis of lung cancer without ALK rearrangement a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study
Contact & Investigator
GIAMPAOLO TORTORA, Prof.
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario A Gemelli
Frequently Asked Questions
Who can join the NCT06234579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ALK Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06234579 currently recruiting?
Yes, NCT06234579 is actively recruiting participants. Contact the research team at dr.emanuele.vita@gmail.com for enrollment information.
Where is the NCT06234579 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06234579 clinical trial?
NCT06234579 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is GIAMPAOLO TORTORA, Prof. at Fondazione Policlinico Universitario A Gemelli. The trial plans to enroll 108 participants.