Actively Recruiting
GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-07-31
108
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced non-small cell lung cancer (NSCLC) patients with ALK gene rearrangements who have progressed on first-line therapy with ALK inhibitors like alectinib. The study aims to explore the use of genomic testing over time to better understand cancer resistance and clinical outcomes under current standard treatments. This observational research focuses on the real-world experience of these patients in Italy. The study involves patients who have received at least 28 days of first-line treatment with ALK inhibitors such as alectinib, brigatinib, or lorlatinib. When disease progression occurs, a multidisciplinary team evaluates the possibility of obtaining tissue or liquid biopsies within two weeks to analyze genetic changes. If biopsies are not feasible or insufficient, blood samples will be collected for circulating tumor DNA (ctDNA) analysis. This approach helps monitor genomic alterations and clonal evolution. Participants will be monitored over five years to assess the availability of next-generation sequencing (NGS) testing at diagnosis and after progression. Researchers will track progression-free survival related to the first-line ALK inhibitor treatment. Patient evaluations include genomic testing from biopsies or blood samples. The study requires informed consent and regular follow-up visits, but no investigational treatments are administered. This long-term observation provides insight into the biology of ALK-positive NSCLC and treatment resistance.
CONDITIONS
Brief Title
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced NSCLC with ALK rearrangement detected by NGS, or by FISH, IHC, or RT-PCR if adequate tissue for NGS is available
- Received upfront treatment with alectinib, brigatinib, or lorlatinib for at least 28 days
- ECOG Performance Status between 0 and 2
- Adult patients aged 18 years or older at diagnosis
- Signed informed consent approved by the local Ethics Committee
You will not qualify if you...
- Diagnosis of lung cancer without ALK rearrangement
- Early withdrawal from treatment due to toxicity without evidence of radiological disease progression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Ongoing throughout the study
Participants undergo biopsies or blood draws to analyze genomic alterations at diagnosis and upon disease progression.
Biopsy or blood draw at diagnosis and repeat biopsies or blood draws within 2 weeks after progression
Duration - Up to 5 years
Participants are observed over time to assess genomic changes and treatment outcomes in ALK-positive NSCLC.
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
E
Emanuele Vita, MD
E
EMILIO Bria, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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