Assessing genomic changes in ALK-positive lung cancer patients
"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate".
This study looks at how genetic changes in ALK-positive lung cancer patients affect their treatment response over time to help improve future care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | alectinib, brigatinib, lorlatinib |
| Locations | 1 site (Rome) |
| Trial ID | NCT06234579 on ClinicalTrials.gov |
What this trial studies
The GALILEO project aims to evaluate genomic alterations and clonal evolution in patients with ALK-positive non-small cell lung cancer (NSCLC) through longitudinal assessments in routine clinical practice in Italy. This observational study will involve biopsies, either tissue or liquid, to gather data on resistance mechanisms and clinical outcomes following standard treatments. By analyzing these genomic changes over time, the study seeks to provide insights into the effectiveness of current therapies and the evolution of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced NSCLC confirmed to have ALK rearrangements and who have received specific ALK inhibitors for at least 28 days.
Not a fit: Patients with lung cancer that does not have ALK rearrangement or those who have withdrawn from treatment due to toxicity without evidence of disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of resistance mechanisms in ALK-positive NSCLC, leading to improved treatment strategies for patients.
How similar studies have performed: Other studies focusing on genomic alterations in cancer have shown promise, indicating that this approach may yield valuable insights, although the specific methodology of this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- Fondazione Policlinico Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: GIAMPAOLO TORTORA, Prof. — Fondazione Policlinico Universitario A Gemelli
- Study coordinator: Emanuele Vita, MD
- Email: dr.emanuele.vita@gmail.com
- Phone: 3480510228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.