Actively Recruiting
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-07-31
108
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
-
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
You will not qualify if you...
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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
E
Emanuele Vita, MD
CONTACT
E
EMILIO Bria, Prof.
CONTACT
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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