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.
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)
None
Patients with newly diagnosed ALK+ NSCLC who are candidate to receive first-line therapy with II-III genaration ALK-inhibitor (alectinib, brigatinib or lorlatinib)
Cohort
Prospective
Biopsy (tissue or liquid)
Diagnostic testAt 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.
Percentage of patients with available NGS testing at diagnosis
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
Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy
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
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
PFS to first-line treatment with II-III generation ALK-inhibitor
PFS to first-line, stratified according to ALK-rearrangement variants
PFS to first-line treatment with II-III generation ALK-inhibitor
PFS to first-line, stratified according to NGS-based mutational profiling
OS to first-line treatment with II-III generation ALK-inhibitor
OS to first-line, stratified according to ALK-rearrangement variants
OS to first-line treatment with II-III generation ALK-inhibitor
OS to first-line, stratified according to NGS-based mutation profiling
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